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ADERS ® uses NDC barcodes to prevent medication errors

Practical Compliance Solutions, Corp. helps care facilities reduce risk at the patient's bedside. Our five rights barcode solution is the easiest to implement. Our barcode point of care system can help prevent medication errors in hospitals, long term care facilities, and assisted living communities.

ADERS ® is our newest barcode solution for the healthcare industry. It helps eliminate medication errors by allowing caregivers to scan NDC barcodes at the patient's bedside, verifying right patient, right drug, right time, right dose, and right route of administration. For more information click the products menu or send us a web request from our Contact menu. Ask for a DEMO CD. It is the full product that is licensed for an evaluation period.

We are offering a 30 day no-obligation free trial of the ADERS ® software. Care facilities can easily determine if ADERS ® is right for them by using the software as a pilot for a single unit or ward. Click here to download a Microsoft Project plan showing how you can implement a five rights point of care barcode pilot in less than a week. If you Don't own MS Project 2003, then here is a PDF copy just to see....

View a PowerPoint Presentation of ADERS ®. With Sound Approximately 11 Minutes. No Sound at Your Pace.

Share this information with a friend by clicking this link. Preventing medication errors with barcodes.

Get The Latest Patient Safety and Drug Safety Updates from the FDA

Food and Drug Administration--Press Releases

FDA Approves Botox to Treat Spasticity in Flexor Muscles of the Elbow, Wrist and Fingers
Tue, 09 Mar 2010 16:42:00 -0500

The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxin A) to treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Spasticity is common after stroke, traumatic brain injury, or the progression of multiple sclerosis.

FDA Update on the Investigation into the Salmonella Montevideo Outbreak - March 5, 2010
Fri, 05 Mar 2010 18:57:00 -0500

As part of the Salmonella Montevideo investigation, the Food and Drug Administration has been actively investigating the supply chain of black and red pepper supplied to Daniele International Inc., Pascoag, R.I.

FDA Investigation Reveals Salmonella Tennessee at Plant that Makes Flavor Enhancers for Food Processors and Other Distributors
Thu, 04 Mar 2010 15:26:00 -0500

The U.S. Food and Drug Administration is actively investigating positive findings of Salmonella Tennessee in hydrolyzed vegetable protein (HVP) manufactured by Basic Food Flavors Inc. in Las Vegas, Nev. HVP is a flavor enhancer used in a wide variety of processed food products such as soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings. It is often blended with other spices to make seasonings that are used in or on foods. There are no reports of consumer illness associated with this recall. Only HVP manufactured by Basic Food Flavors is involved in this recall.

FDA Approves Name Change for Heartburn Drug Kapidex
Thu, 04 Mar 2010 14:32:00 -0500

The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex Change to Dexilant is part of FDA effort to prevent medication errors(dexlansoprazole) to avoid confusion with two other medications – Casodex and Kadian. Effective in late April 2010, Takeda Pharmaceuticals North America Inc. will market Kapidex under the new name Dexilant.

La FDA advierte a los consumidores en Puerto Rico acerca de la presencia de una bacteria dañina en desinfectantes para manos
Wed, 03 Mar 2010 17:59:00 -0500

La Administración de Medicamentos y Alimentos (FDA por sus siglas en inglés) está advirtiendo a los consumidores en Puerto Rico acerca de un alto contenido de la bacteria Burkholderia cepacia en los desinfectantes para manos: "Bee-Shield Hand Sanitizer” con Aloe Vera ( botellas de 10 onzas o de un galón) y “MD Quality Hand Sanitizer” con Aloe Vera (botellas de 10 onzas). La bacteria Burkholderia cepacia puede causar infecciones graves en las personas.

FDA Warns Consumers in Puerto Rico of Harmful Bacteria in Hand Sanitizers
Wed, 03 Mar 2010 17:59:00 -0500

The U.S. Food and Drug Administration is warning consumers in Puerto Rico that two hand sanitizers – "Bee-Shield Hand Sanitizer” with Aloe Vera (10 fl. oz. or 1 gallon bottles) and “MD Quality Hand Sanitizer” with Aloe Vera (10 fl oz. bottles) – contain high levels of a bacteria, Burkholderia cepacia, that can cause serious infections in humans.

FDA, FSIS, CDC Collaborate on Methods to Measure Success of Food Safety Programs
Wed, 03 Mar 2010 13:35:00 -0500

The U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) will host a joint public workshop on how best to measure progress in reducing foodborne illnesses on March 30, in Washington, D.C.

FDA Calls on Food Companies to Correct Labeling Violations; FDA Commissioner Issues an Open Letter to the Industry
Wed, 03 Mar 2010 12:54:00 -0500

The U.S. Food and Drug Administration has notified 17 food manufacturers that the labeling for 22 of their food products violates the Federal Food, Drug, and Cosmetic Act.

FDA Survey Finds More Americans Read Information on Food Labels
Tue, 02 Mar 2010 17:09:00 -0500

A majority of consumers read food labels and are increasingly aware of the link between good nutrition and reducing the risk of disease, according to the latest survey of dietary habits released today by the U.S. Food and Drug Administration.

FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland
Tue, 02 Mar 2010 15:12:00 -0500

The U.S. Food and Drug Administration today approved the first generic version of Flomax Capsules 0.4 mg (tamsulosin hydrochloride) to treat benign prostatic hyperplasia (BPH), a condition in which an enlarged prostate gland causes problems with urination.

U.S. Attorney News Release: Boca Raton Man Sentenced for Nutritional Supplement Scam
Tue, 02 Mar 2010 11:30:00 -0500

Jeffrey H. Sloman, United States Attorney for the Southern District of Florida, David W. Bourne, Special Agent in Charge, Food and Drug Administration, Office of Criminal Investigations, Daniel W. Auer, Special Agent in Charge, Internal Revenue Service, Criminal Investigation Division, and Henry Gutierrez, Postal Inspector in Charge, U.S. Postal Inspection Service, announced the February 26, 2010 sentencing of defendant Frank Sarcona, a/k/a Frank Sarcone, a/k/a Dave Johnson, 58, of Boca Raton, FL. U.S. District Court Judge Kenneth A. Marra sentenced Sarcona to a term of 20 years’ imprisonment for conspiracy to commit mail and wire fraud, and criminal contempt of court; conspiracy to commit money laundering; and multiple counts of substantive mail fraud, wire fraud, money laundering, misbranding of a food, and criminal contempt of court.

FDA Announces Meeting Information and Voting Membership of the Tobacco Products Scientific Advisory Committee
Mon, 01 Mar 2010 10:37:00 -0500

The U.S. Food and Drug Administration today announced membership and meeting information for the Tobacco Products Scientific Advisory Committee (TPSAC). The Committee, required through the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), will provide advice, information, and recommendations to FDA on a wide range of tobacco-related issues.

International Collaboration: FDA and European Medicines Agency Agree to Accept a Single Orphan Drug Designation Annual Report
Sat, 27 Feb 2010 07:23:00 -0500

In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions.

FDA Update on the Investigation into the Salmonella Montevideo Outbreak - February 26, 2010
Sat, 27 Feb 2010 07:05:00 -0500

The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

FDA Approves Therapy to Treat Gaucher Disease
Fri, 26 Feb 2010 19:26:00 -0500

The U.S. Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.

U.S. Attorney News Release: Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety
Fri, 26 Feb 2010 15:03:00 -0500

U.S. Attorney News release: Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA

FDA Update on the Investigation into the Salmonella Montevideo Outbreak - February 25, 2010
Thu, 25 Feb 2010 21:08:00 -0500

The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

U.S. Attorney News Release: Medical Technician Sentenced to 30 Years
Thu, 25 Feb 2010 09:07:00 -0500

Statement by U.S. attorney David Gaouette regarding the sentencing of Kristen Parker

FDA Approves Pneumococcal Disease Vaccine with Broader Protection
Wed, 24 Feb 2010 12:10:00 -0500

The U.S. Food and Drug Administration today approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. Prevnar 13 will be the successor to Prevnar, the pneumococcal 7-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease (IPD) and otitis media. The new vaccine extends the protection to six additional types of the disease causing bacteria.

NIH and FDA Announce Collaborative Initiative to Fast-track Innovations to the Public
Wed, 24 Feb 2010 10:12:00 -0500

The U.S. Food and Drug Administration and the National Institutes of Health today unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients.

Food and Drug Administration--Recalls/Safety Alerts

Nutritional Resources Announces a Nationwide Voluntary Recall of Healthwise Cream of Mushroom Soup Due to Possible Health Risk
Wed, 10 Mar 2010 11:28:00 -0500

As a precautionary measure, Nutritional Resources, Inc announced, it is voluntarily recalling one production code of Healthwise Cream of Mushroom Soup because an ingredient used in the product has the potential to be contaminated with Salmonella. Salmonella is a common food borne pathogen that can cause severe illnesses, including fever, abdominal cramps and diarrhea.

Herr Foods Inc. Recalls 'Herr's Cracked Pepper and Sea Salt Flavored' Kettle Style Potato Chips Because of Possible Health Risk
Tue, 09 Mar 2010 16:31:00 -0500

As a precautionary measure and concern for our consumer safety, Herr Foods Inc of Nottingham, PA is voluntarily recalling ‘Herr’s Cracked Pepper and Sea Salt Flavored’ Kettle Style Potato Chips. The product is being recalled because it contains HVP (hydrolyzed vegetable protein) manufactured, distributed and recalled by Basic Food Flavors, Inc., Las Vegas, NV.

Dutch Valley Food Distributors, Inc. Announces a Voluntary Nationwide Recall of Black Pepper and Products made with Black Pepper
Tue, 09 Mar 2010 15:57:00 -0500

As a result of a recall of Black Pepper by Mincing Overseas Spice Company and distributed by Dutch Valley Food Distributors due to the possibility of contamination with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems, a product recall is being issued. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain.

GNS Foods Voluntarily Recalls Snack Mixes Containing Honey Mustard/Onion Pretzels from National Pretzel Co. associated with Hydrolyzed Vegetable Protein (HVP) recalled by Basic Food Flavors, Inc. because of the potential Salmonella contamination.
Tue, 09 Mar 2010 15:23:00 -0500

GNS Foods, Inc. is announcing a voluntary recall of mixes containing certain pretzels. The products contain the ingredient Hydrolyzed Vegetable Protein (HVP) being recalled by Basic Food Flavors because of the potential to contain salmonella.

Nature's Variety Expands Nationwide Voluntary Recall to Include All Raw Frozen Chicken Diets with Any "Best If Used By" Date On or Before 2/5/11
Tue, 09 Mar 2010 14:45:00 -0500

Nature’s Variety has expanded its voluntary recall of Chicken Formula Raw Frozen Diets for dogs and cats to include the “Best If Used By” dates of 10/29/10 and 11/9/10 because these products may be contaminated with Salmonella. Salmonella can affect animals and there is risk to humans from handling contaminated pet products.

National Pretzel Co. Annouces Precautionary Recall of Honey Mustard Onion Seasoned Pretzels Because of Possible Health Risk
Sat, 06 Mar 2010 22:04:00 -0500

As a precautionary measure, National Pretzel Company of Lancaster, Pa. is voluntarily recalling all Honey Mustard Onion flavored pretzels produced since December, 2009 because an ingredient used in the seasoning has the potential to be contaminated with Salmonella. The honey mustard onion seasoning contains Hydrolyzed Vegetable Protein (HVP) which was recalled by Basic Foods Flavors, Inc. and has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Estrella Family Creamery Recalls Old Apple Tree Tomme Cheese Due to Possible Health Risks
Sat, 06 Mar 2010 22:01:00 -0500

The Estrella Family Creamery of Montesano, Washington, is recalling a production of Old Apple Tree Tomme cheese because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infections can cause miscarriages and stillbirths among pregnant women.

Ed Roller, Inc. Announces Voluntary Recall of Wegmans 9 oz. Food You Feel Good About® Medium Seafood Sauce Due to Undeclared Ingredients on Label
Fri, 05 Mar 2010 22:12:00 -0500

Ed Roller, Inc. of Rochester, NY is voluntarily recalling Wegmans Food You Feel Good About® Medium Seafood Sauce, 9 ounce glass jar, UPC #77890 84032, because the product may contain undeclared soy and anchovies. Only those jars with a sell-by date up to and including April 21 are included in this recall. The sell-by date is heat stamped on the label.

Mincing Overseas Spice Company Voluntarily Recalls Two Lots of Black Pepper
Fri, 05 Mar 2010 22:10:00 -0500

Mincing Overseas Spice Company of Dayton, New Jersey announced today that it is recalling black pepper Lots 3258 and 3309 because of possible contamination with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Fresh Food Concepts Announces a Voluntary Recall of Spinach Dips Due to Possible Health Risk
Fri, 05 Mar 2010 19:38:00 -0500

As a precautionary measure, Fresh Food Concepts, Inc. announced, it is voluntarily recalling certain production codes of Delicioso, De la Casa, Rojo’s and Fresh Food Concepts brand Spinach Dips and Fresh Food Concepts Spinach Dip with Yogurt because an ingredient used in those products has the potential to be contaminated with Salmonella. Salmonella is a common food borne pathogen that can cause severe illnesses, including fever, abdominal cramps and diarrhea.

McCormick & Company Initiates Recall Due to Possible Health Risk from HVP Ingredient
Fri, 05 Mar 2010 19:37:00 -0500

McCormick & Company, Incorporated (NYSE:MKC) is initiating a recall of products manufactured with HVP (hydrolyzed vegetable protein) supplied by Basic Food Flavors of Las Vegas, Nevada, because the ingredient has the potential to be contaminated with Salmonella. "Consumption of products containing Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms) endocarditis and arthritis."

Creative Contract Packaging Corporation Recalls HERB-OX® Bouillon Products Because of Possible Health Risk
Fri, 05 Mar 2010 16:47:00 -0500

This action is being taken after Basic Food Flavors, Inc. ("Basic") issued a recall for all Hydrolyzed Vegetable protein ("HVP") dry powder manufactured by Basic Food Flavors on or after September 17, 2009, due to a positive test result for Salmonella in a production lot. Our records indicate that some of the HVP being recalled by Basic Food Flavors was used as an ingredient in HERB-OX® items.

Concord Foods Recalls Concord Foods Seasonings Mixes because of Possible Health Risk
Fri, 05 Mar 2010 14:55:00 -0500

Brockton, MA-Concord Foods Inc is voluntarily recalling certain production codes of Concord Foods Vegetable Dip Seasoning mix that is generally sold in the produce department of supermarkets because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

Reser's Fine Foods Inc Press Release
Thu, 04 Mar 2010 11:35:00 -0500

Reser's Fine Foods, Inc. of Beaverton, OR has been notified by a supplier that certain seasoning ingredients it supplied to Reser's contain hydrolyzed vegetable protein (HVP) that may be contaminated with Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Earth Island Announces Voluntary Recall On Select Follow Your Heart Products That Contain Natural Flavor Because Of Possible Health Risk
Wed, 03 Mar 2010 21:39:00 -0500

Earth Island is conducting a voluntary recall on its distribution of the following Follow Your Heart brand products as a precautionary measure due to possible Salmonella contamination of a natural flavor from one of our suppliers. The recalled products contain natural flavor supplied by Basic Food Flavors of Las Vegas, Nevada...

Homemade Gourmet Voluntarily Recalls "Tortilla Soup Mix" Because of Possible Health Risk
Wed, 03 Mar 2010 19:45:00 -0500

Homemade Gourmet of Canton, Texas is voluntarily recalling approximately 320 packages of 1.96 oz Tortilla Soup Mix, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

Tim's Cascade Snacks Recalls 'Hawaiian^® Kettle Style Potato Chips - Sweet Maui Onion' and 'Hawaiian- Sweet Maui Onion Rings' Because of Possible Health Risk
Wed, 03 Mar 2010 07:24:00 -0500

Out of regard and concern for our consumers, Tim’s Cascade Snacks of Algona, Washington is recalling ‘HAWAIIAN® Kettle Style Potato Chips - SWEET MAUI ONION’ AND ‘HAWAIIAN - SWEET MAUI ONION RINGS’ because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Castella Imports, Inc. Conducts Nationwide Recall of Castella Chicken Soup Base Because of Possible Health Risk
Tue, 02 Mar 2010 22:52:00 -0500

Castella Imports of Hauppauge, NY, is voluntarily recalling Castella Chicken Soup Base because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

T. Marzetti Company Announces a Voluntary Recall of Dips Due to Possible Health Risk
Tue, 02 Mar 2010 11:16:00 -0500

T. Marzetti Company today announced as a precautionary measure that it is voluntarily recalling certain production codes of T. Marzetti Veggie Dips, Oak Lake Chip Dips and Great Value Chip Dips because an ingredient used in the product has the potential to be contaminated with Salmonella. There have been no reports of illnesses associated with the identified products, and no other types, varieties of flavors of products are affected by this recall.

Heartland Foods, Inc. voluntarily recalls Coarse Ground Black Pepper because of possible Salmonella Contamination
Mon, 01 Mar 2010 22:31:00 -0500

March 1, 2010 – Indianapolis, IN – Heartland Foods, Inc. of Indianapolis is voluntarily recalling all sizes/containers of COARSE GROUND BLACK PEPPER shipped from their facility at 6815 E. 34th Street, Indianapolis IN. Potential distribution took place on or after October 19th, 2009 to February 17th, 2010. These products have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, the elderly, and other with weakened immune systems.

What's New: Drugs RSS Feed

Current Drug Shortages
Tue, 09 Mar 2010 17:07:00 -0500

Current Drug Shortages: Gemifibrozil Tablets 3/9/2010, Heparin Sodium Large Volume Premixed Infusion Solutions (updated) 3/8/2010, Cerezyme (imiglucerase) Injection (updated) 3/2/2010, Propofol Injection 3/1/2010, Ephedrine Injection 2/25/2010, Propofol Injection (updated) 2/24/2010, Acyclovir Tablets and Capsules (updated) 2/22/2010, Technetium Tc99m Generators (updated) 2/18/2010, Vecuronium Injection (updated) 2/12/2010, Thyroid (desiccated) tablets 2/12/2010, Mexiletine Capsules (150mg, 200mg, and 250mg) 2/12/2010

New and Generic Drug Approvals
Tue, 09 Mar 2010 15:59:00 -0500

Updated 3/9/2010

Paragraph IV Patent Certifications
Tue, 09 Mar 2010 15:35:00 -0500

Updated list.

Pediatric Exclusivity Statistics
Tue, 09 Mar 2010 15:28:00 -0500

Updated list.

Status of OTC Rulemakings
Fri, 05 Mar 2010 11:28:00 -0500

Updated list.

Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)
Fri, 05 Mar 2010 08:05:00 -0500

Updated list.

Drugs@FDA Data Files
Thu, 04 Mar 2010 13:26:00 -0500

Data files updated through March 3, 2010.

ANDA (Generic) Drug Approvals
Thu, 04 Mar 2010 08:55:00 -0500

Updated listing.

Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
Mon, 01 Mar 2010 14:41:00 -0500

National Drug Code Directory
Mon, 01 Mar 2010 08:40:00 -0500

The National Drug Code has been updated with data through February 2010.

Non-Inferiority Clinical Trials
Fri, 26 Feb 2010 08:40:00 -0500

FDA Drug Safety Communication: Ongoing review of Avandia (rosiglitazone) and cardiovascular safety
Thu, 25 Feb 2010 10:49:00 -0500

The U.S. Food and Drug Administration (FDA) is reviewing data, submitted in August 2009, from a large, long-term clinical study on possible risks with the diabetes drug, Avandia (rosiglitazone).

FDA Drug Safety Communication: Serious liver disorder associated with the use of Videx/Videx EC (didanosine)
Thu, 25 Feb 2010 08:42:00 -0500

[01-29-2010] The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine).

FDA Drug Safety Communication: Ongoing safety review of Invirase (saquinavir) and possible association with abnormal heart rhythms
Wed, 24 Feb 2010 10:05:00 -0500

The U.S. Food and Drug Administration (FDA) is reviewing clinical trial data about a potentially serious effect on the heart from the use of Invirase (saquinavir) in combination with Norvir (ritonavir).

Additions/Deletions for Prescription and OTC Drug Product Lists
Mon, 22 Feb 2010 16:20:00 -0500

The list has been updated through August 2009.

Orange Book Current Cumulative Supplement
Mon, 22 Feb 2010 16:18:00 -0500

January 2010 Cumulative Supplement

Information for Healthcare Professionals: Cefepime (marketed as Maxipime)
Mon, 22 Feb 2010 15:29:00 -0500

The purpose of this communication is to share information about the FDA’s continuing safety review about the potential increased mortality in patients treated with cefepime. Cefepime is a cephalosporin antibacterial and is a member of the ß–lactam class of antibacterial drugs.

FDA Drug Safety Communication: New safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)
Mon, 22 Feb 2010 09:03:00 -0500

Due to safety concerns, the U.S. Food and Drug Administration (FDA) is requiring changes to how long-acting inhaled medications called Long-Acting Beta-Agonists (LABAs) are used in the treatment of asthma.

Warning Letters 2010
Fri, 19 Feb 2010 14:17:00 -0500

Letters added

FDA Drug Safety Communication: Product Confusion with Maalox Total Relief and Maalox Liquid Products
Fri, 19 Feb 2010 11:57:00 -0500

The U.S. Food and Drug Administration (FDA) has received five reports of serious medication errors involving consumers who used Maalox Total Relief, the upset stomach reliever and anti-diarrheal medication, by mistake, when they had intended to use one of the traditional Maalox liquid antacid products.

What's New: Drugs RSS Feed

New and Generic Drug Approvals
Tue, 09 Mar 2010 15:59:00 -0500

Updated 3/9/2010

Paragraph IV Patent Certifications
Tue, 09 Mar 2010 15:35:00 -0500

Updated list.

Pediatric Exclusivity Statistics
Tue, 09 Mar 2010 15:28:00 -0500

Updated list.

Status of OTC Rulemakings
Fri, 05 Mar 2010 11:28:00 -0500

Updated list.

Drugs@FDA Data Files
Thu, 04 Mar 2010 13:26:00 -0500

Data files updated through March 3, 2010.

ANDA (Generic) Drug Approvals
Thu, 04 Mar 2010 08:55:00 -0500

Updated listing.

Submission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
Mon, 01 Mar 2010 14:41:00 -0500

National Drug Code Directory
Mon, 01 Mar 2010 08:40:00 -0500

The National Drug Code has been updated with data through February 2010.

Non-Inferiority Clinical Trials
Fri, 26 Feb 2010 08:40:00 -0500

Additions/Deletions for Prescription and OTC Drug Product Lists
Mon, 22 Feb 2010 16:20:00 -0500

The list has been updated through August 2009.

Orange Book Current Cumulative Supplement
Mon, 22 Feb 2010 16:18:00 -0500

January 2010 Cumulative Supplement

Warning Letters 2010
Fri, 19 Feb 2010 14:17:00 -0500

Letters added

What's New: Vaccines, Blood & Biologics RSS Feed

Influenza A (H1N1) 2009 Monovalent Vaccines Composition and Lot Release
Wed, 10 Mar 2010 11:26:00 -0500

Vaccine lot release information updated on 3/3/2010.

DIA/FDA CDER/CBER Computational Science Annual Meeting
Thu, 04 Mar 2010 21:55:00 -0500

This meeting will review progress on topics such as data standards, best practices-driven analytical tool development, business processes driving information systems development, and user experience/evaluation of current tools.

Hizentra
Thu, 04 Mar 2010 16:03:00 -0500

Cord Blood Licensure: A Workshop
Thu, 04 Mar 2010 15:37:00 -0500

March 8 - 9, 2010

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