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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 generic versions of blood thinner Plavix
Thu, 17 May 2012 13:04:00 -0500

The U.S. Food and Drug Administration today approved generic versions of the blood thinning drug Plavix (clopidogrel bisulfate), which helps reduce the risk of heart attack and stroke by making it less likely that platelets in the blood will clump and form clots in the arteries.

FDA expands use for FilmArray Respiratory Panel
Tue, 15 May 2012 12:29:00 -0500

The U.S. Food and Drug Administration today expanded the use for the FilmArray Respiratory Panel, the first test that can simultaneously detect both viral and bacterial causes of respiratory infection from a single sample.

FDA issues alert on potential dangers of unproven treatment for multiple sclerosis
Thu, 10 May 2012 07:58:00 -0500

The U.S. Food and Drug Administration is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).

FDA proposal aims to help reduce unnecessary radiation exposure for children
Wed, 09 May 2012 08:00:00 -0500

Today, the U.S. Food and Drug Administration announced that it is seeking public comment on a proposal encouraging manufacturers to consider the safety of children in the design of new X-ray imaging devices. In the draft guidance, FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients.

FDA issues final rule on sterility testing of biological products
Thu, 03 May 2012 12:52:00 -0500

The U.S. Food and Drug Administration issued its final rule on sterility testing, amending the requirements for most licensed biological products.

FDA permits marketing of a new device for abdominal surgery
Tue, 01 May 2012 16:52:00 -0500

On April 30, the U.S. Food and Drug Administration today allowed marketing of the first surgical instrument set that can be assembled and disassembled inside the body during surgery. The Percutaneous Surgical Set is intended to be used during minimally invasive laparoscopic abdominal surgery, in which a camera and surgical instruments are inserted through one or more small incisions (surgical cuts into body tissue) in the abdomen.

FDA approves new orphan drug to treat a form of Gaucher disease
Tue, 01 May 2012 15:09:00 -0500

The U.S. Food and Drug Administration today approved Elelyso (taliglucerase alfa) for long-term enzyme replacement therapy to treat a form of Gaucher disease, a rare genetic disorder.

FDA approves new antibacterial treatment for plague
Mon, 30 Apr 2012 08:24:00 -0500

The U.S. Food and Drug Administration today approved Levaquin (levofloxacin) to treat patients with plague, a rare and potentially deadly bacterial infection. The agency also approved the drug to reduce the risk of getting plague after exposure to Yersinia pestis, the bacterium that causes the disease.

FDA approves Stendra for erectile dysfunction
Fri, 27 Apr 2012 12:47:00 -0500

The U.S. Food and Drug Administration today approved Stendra (avanafil), a new drug to treat erectile dysfunction.

FDA challenges marketing of DMAA products for lack of safety evidence
Fri, 27 Apr 2012 13:56:00 -0500

The U.S. Food and Drug Administration today issued warning letters to ten manufacturers and distributors of dietary supplements containing dimethylamylamine, more popularly known as DMAA, for marketing products for which evidence of the safety of the product had not been submitted to FDA.

FDA approves Votrient for advanced soft tissue sarcoma
Thu, 26 Apr 2012 16:47:00 -0500

The U.S. Food and Drug Administration today approved Votrient (pazopanib) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy. Soft tissue sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, and other tissues.

FDA approves Afinitor for non-cancerous kidney tumors caused by rare genetic disease
Thu, 26 Apr 2012 15:33:00 -0500

The U.S. Food and Drug Administration today approved Afinitor (everolimus), the first drug approved specifically to treat non-cancerous kidney tumors (renal angiomyolipomas) not requiring immediate surgery in patients with tuberous sclerosis complex (TSC).

FDA Statement on USDA Announcement of Positive BSE Test Result
Thu, 26 Apr 2012 08:20:00 -0500

This week, the U.S. Department of Agriculture (USDA) confirmed that a dairy cow in California tested positive for atypical bovine spongiform encephalopathy (BSE, or "mad cow" disease). The USDA also confirmed the cow did not enter the animal feed or human food supply. The U.S. Food and Drug Administration is working with federal and state authorities to further investigate this case.

FDA strengthens international collaboration to ensure quality, safety of imported products
Mon, 23 Apr 2012 08:54:00 -0500

The U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. today released the agency’s “Global Engagement Report” [INSERT HYPERLINK], detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency.

Report: FDA strengthens monitoring of post-approval drug safety
Sat, 21 Apr 2012 12:03:00 -0500

A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in the U.S. Food and Drug Administration’s oversight of drugs once they reach the American public, according to a new report released today by the agency’s Center for Drug Evaluation and Research (CDER). The report, “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that give the same priority to postmarket drug safety monitoring as to premarket drug review.

FDA issues draft guidance on nanotechnology
Fri, 20 Apr 2012 13:24:00 -0500

Two draft guidance documents that address the use of nanotechnology by the food and cosmetics industries were issued today by the U.S. Food and Drug Administration.

U.S. Marshals seize ultrasound gel product at a New Jersey company
Wed, 18 Apr 2012 13:50:00 -0500

U.S. Marshals, acting at the request of the Food and Drug Administration, today seized Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations Inc. in Newark, N.J. after an FDA analysis found that product samples contained dangerous bacteria.

Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product
Fri, 13 Apr 2012 17:54:00 -0500

• Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a ground product. • The product is not available for sale to individual consumers, but may have been used to make sushi, sashimi, ceviche and similar dishes available in restaurants and grocery stores. • The company name and Nakaochi Scrape AA or AAA were printed on boxes of the product when it was initially sold to distributors. However, the boxes may have been broken into smaller lots for further sale and may not be available to the end retailer or consumer. Therefore, the tuna may not be readily identifiable by retail outlets or by consumers as being from the implicated lots. • The Nakaochi Scrape AA and AAA from MMI was sold through distributors to restaurants and grocery stores that make sushi, and has been linked to an outbreak of Salmonella Bareilly, which has caused 116 illnesses in 20 states and the District of Columbia to date. Of the reported illnesses, there have been 12 hospitalizations, and no deaths. • Many of the people who became ill reported eating raw tuna in sushi as “spicy tuna.” • If you purchase “spicy tuna” or other sushi, sashimi, ceviche, or similar dishes that might contain Nakaochi Scrape from a restaurant or grocery store, check with the establishment to make sure that it does not contain raw recalled product from Moon Marine USA Corporation, also known as MMI. When in doubt, don’t eat it. • Consumers who think they might have become ill from eating possibly contaminated raw Nakaochi Scrape should consult their health care providers.

Dept. of Justice enters consent decree with California seafood processor
Wed, 11 Apr 2012 16:10:00 -0500

A California seafood importer and processor has agreed to a consent decree with the FDA that prevents the company from manufacturing or distributing fish or fish products until it has corrected conditions in its seafood processing facility alleged to be contaminated with Listeria monocytogenes (L. mono) bacteria.

FDA takes steps to protect public health
Wed, 11 Apr 2012 11:34:00 -0500

The U.S. Food and Drug Administration announced today that it is taking three steps to protect public health and promote the judicious use of medically important antibiotics in food-producing animals.

Food and Drug Administration--Recalls/Safety Alerts

River Ranch Expands Salad Recall Because Of Possible Health Risk
Sun, 20 May 2012 14:52:00 -0400

River Ranch Fresh Foods, LLC of Salinas, CA is expanding its voluntary recall of retail and foodservice bagged salads, because they have the potential of being contaminated with Listeria monocytogenes.

Gills Onions Voluntarily Recalls One Lot of Diced Red Onions Because of Possible Health Risk
Sat, 19 May 2012 20:01:00 -0400

Gills Onions, LLC of Oxnard, CA is initiating a voluntary recall, 2,360 pounds, of diced red onions with lot code 51RDA1A2119 and use-by-dates May 14, 15 and 17, 2012 because it may be contaminated by Listeria monocytogenes. The product is beyond its use-by-date, no illnesses have been reported in connection with this recall, and no other Gills Onions product is affected by this recall.

Caribe Produce, LTD CO. Recalls Papaya Maradol, Caribena Brand Because Of Possible Health Risk
Fri, 18 May 2012 23:54:00 -0400

Caribe Produce LTD Co. of McAllen, TX, is recalling 286 cases of Papaya Maradol, Caribeña Brand papayas packed in 35 lb. cartons marked with the brand “ Caribeña “ and “ Product of Mexico” stamped on the side. The papayas are sold individually, and each one bears a label which states “3112 CARIBENA Papaya MARADOL PRODUCT OF MEXICO

River Ranch Recalls Retail And Food Service Salads Because Of Possible Health Risk
Fri, 18 May 2012 23:21:00 -0400

River Ranch Fresh Foods, LLC of Salinas, CA is initiating a voluntary recall of retail and foodservice bagged salads,because they have the potential of being contaminated with Listeria monocytogenes following routine random retail salad finished product tests conducted in the marketplace by the Food & Drug Administration.

WEST COAST NUTRITIONALS, LTD. Issues a Voluntary Worldwide/Nationwide Drug Recall of Products FIRMINITE, EXTRA STRENGTH INSTANT HOT ROD, AND LIBIDRON due to Undeclared Tadalafil
Fri, 18 May 2012 22:47:00 -0400

WEST COAST NUTRITIONALS, LTD is conducting a voluntary recalling all lots of FIRMINITE, EXTRA STRENGTH INSTANT HOT ROD, AND LIBIDRON capsules to the consumer level. An FDA lab analysis of FIRMINITE distributed by West Coast Nutritionals was found to contain undeclared Tadalafil.

Santos Agency, Inc. voluntarily recalls Santos Brands Products for undeclared peanuts and wheat in California
Fri, 18 May 2012 21:55:00 -0400

Santos Agency, Inc. has initiated a recall of Santos Brand products i.e. various kinds of flours, legumes and spices because they may contain undeclared peanuts and wheat.

Bakery El Monte Sinai Corp Announces Allergy Alert on Undeclared Eggs in Rainbow Cake
Wed, 16 May 2012 21:31:00 -0400

Bakery El Monte Sinai Corp., located at 100 A North Franklin Street in Hempstead, New York 11550, is recalling rainbow cake because it may contain undeclared eggs.

Hospira Announces A Nationwide Voluntary Recall Of One Lot Of Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject, That May Contain More Than The Intended Fill Volume
Sat, 12 May 2012 14:03:00 -0400

Hospira, Inc. (NYSE: HSP), announced today it is initiating a voluntary user level recall of one lot of Hydromorphone Injection, USP, 1 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1283-31, due to two reported complaints of a single Carpuject containing more than the 1 mL labeled fill volume. Opioid pain medications such as Hydromorphone have life-threatening consequences if overdosed.

NestlÃ© Purina Voluntarily Recalls Single Lot of Therapeutic Canned Cat Food Due to A Low Level of Thiamine (Vitamin B1)
Fri, 11 May 2012 21:01:00 -0400

NestlÃ© Purina PetCare (NPP) is voluntarily recalling one specific lot of its Purina Veterinary DietsÂ® OM Overweight Management canned cat food, available through veterinarians in the U.S. and Canada. This precautionary measure is being taken in response to one consumer complaint received by FDA.

Correction to Date Code in Natural Balance Pet Foodsâ€™ Voluntary Recall Dated May 4, 2012 Due to the Potential for Salmonella Contamination
Fri, 11 May 2012 20:15:00 -0400

On May 4, 2012, Natural Balance Pet Foods announced a voluntary recall of certain dry pet food formulas manufactured by Diamond Pet Foods at their Gaston, South Carolina facility. Link to original press release: http://www.fda.gov/Safety/Recalls/ucm303042.htm

Whole Foods Market recalls carrot cake cupcakes for undeclared walnuts in Northern California
Fri, 11 May 2012 20:12:00 -0400

Whole Foods Market is recalling its variety cupcake six-packs sold in stores in Northern California because some of the products contain undeclared walnuts. One illness has been reported to date, and people who have allergies to walnuts run the risk of serious or life-threatening allergic reaction if they consume these products.

Jonlly Fruits Inc. Issues Allergy Alert On Undeclared Allergens In Several Products
Fri, 11 May 2012 12:45:00 -0400

Jonlly Fruits Inc., Bayamón, PR, is alerting consumers about their brands Jonlly Fruit and Natural Tropic: China (Orange), Acerola (Wild Cherry), Uva (Grape), Parcha (Passion Fruit), Fruta (Fruit Punch), Limón (Lemon), Toronja (Grapefruit), Guava-Piña (Guava-Pineapple), Guanábana (Soursop), China Light (Orange Light), Mandarin (Mandarina), and China-Zanahoria (Orange-Carrot) because it may contain undeclared sodium caseinate (a milk derivative). People who are allergic or are severely sensitive to milk run the risk of a serious or a life-threatening allergic reaction if they consume these products.

Jonlly Fruits Inc. Alerta De Alergia Por No Decrarar Alergenos En El Producto
Fri, 11 May 2012 12:45:00 -0400

Jonlly Fruits Inc. de Bayamon PR, hace un llamado al cosumidor de sus productos Jonlly Fruit Y Natural Tropic; China, Acerola, Uva, Parcha, Frutas, Limón, Toronja, Guanabana, Guava Piña, China Light, Mandarina, China Zanahoria. Porque prodria contener un tipo de alergeno no declarado en la etiqueta, específicamente; Partilly Hydrogenated Coconut oil, Corn Syrup Solids, Sodium Caseinate (a Milk Derivative), Xanthan Gum, Mono-And Diglycerides, Dipotassium Phosphate, Contains 2% or less of Sodium Silicoaluminate and Soy Lecithin.

Moon Fishery (India) Pvt. Ltd. Recalls Its "Tuna Strips" Product Of India "AA" Or "AAA" Grade Because Of Possible Health Risk
Wed, 09 May 2012 14:15:00 -0400

Moon Fishery (India) Pvt. Ltd., the Manufacturer of the Yellow Fin Tuna Nakaochi Scrape that was recently recalled by a U.S. Distributor, is also recalling its 22 pound cases of "Tuna Strips" Product of India AA or AAA GRADE 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, nausea, vomiting and abdominal pain.

Solid Gold Health Products for Pets, Inc. Recalls Dog Food Because of Possible Salmonella Health Risk
Tue, 08 May 2012 17:09:00 -0400

Solid Gold Health Products for Pets, Inc., El Cajon, California, announced a voluntary recall of one batch of WolfCub Large Breed Puppy Food and one batch of Solid Gold WolfKing Large Breed Adult Dog, both with a Best Before date of December 30, 2012, and an "X" in the 11th digit of the date code.

Cleveland Beansprouts Co. of Cleveland, OH is recalling all alfalfa sprouts because they may be contaminated with Listeria monocytogenes
Tue, 08 May 2012 14:11:00 -0400

Cleveland Beansprouts Co. of Cleveland, OH is recalling all alfalfa sprouts because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals 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 infection can cause miscarriages and stillbirths among pregnant women.

Water Pik, Inc. Announces Product Exchange Program
Mon, 07 May 2012 17:41:00 -0400

Water Pik, Inc., a leading developer, manufacturer and marketer of innovative personal healthcare products, will replace certain SinuSense™ Water Pulsator nasal irrigation devices it manufactured between May, 2010 and July, 2011. This program is being offered in response to consumer complaints that water being used in the Pulsator seeped into the battery compartment leading to battery corrosion, possible reservoir contamination and the need to prematurely replace batteries.

Apex Pet Foods Initiates Voluntary Recall of Dry Pet Food Due to the Potential for Salmonella No Pet or Human Illnesses have been Reported Associated With Apex Dog Food
Mon, 07 May 2012 12:51:00 -0400

Apex Pet Foods announced today that it is issuing a voluntary recall of all dry dog food formulas manufactured on January 24, 2012. Although there have been no animal or human illnesses related to Apex Dog Food and the product has not tested positive for Salmonella, the company has voluntarily initiated this recall out of caution to ensure the health and safety of consumers and their pets.

Natural Balance Pet Foods Initiates Voluntary Recall of Certain Dry Pet Food Due to the Potential for Salmonella Contamination
Mon, 07 May 2012 10:46:00 -0400

Natural Balance Pet Foods announced today that it is issuing a voluntary recall of certain dry pet food formulas manufactured by Diamond Pet Foods at their Gaston, South Carolina facility. Although there have been no animal illnesses reported and none of the products included in the recall has tested positive for Salmonella, the company has voluntarily initiated this recall as a precautionary measure.

UPDATED: CORRECT PRODUCTION CODE INFORMATION Canidae Pet Foods Initiates Voluntary Recall of Dry Pet Food Due to the Potential for Salmonella
Mon, 07 May 2012 10:40:00 -0400

Canidae Pet Foods announced today that it is issuing a voluntary recall of certain dry pet food formulas manufactured between December 9, 2011, and January 31, 2012 at the Diamond Pet Food Gaston, South Carolina plant. Although there have been no animal or human illnesses related to Canidae Pet Food, and the product has not tested positive for Salmonella, the company has voluntarily initiated this recall out of caution to ensure the health and safety of consumers and their pets.

What's New: Drugs RSS Feed

New and Generic Drug Approvals
Fri, 18 May 2012 14:33:00 -0500

Drug Approval Listing

Comunicado de la FDA sobre la seguridad de los medicamentos: Informe actualizado sobre la seguridad del medicamento Revlimid (lenalidomida) para el cáncer y el riesgo de nuevos tipos de neoplasias (nuevos tipos de cáncer)
Thu, 17 May 2012 09:06:00 -0500

El 7 de mayo del 2012, la Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) informó al público sobre el aumento en el riesgo de segundas neoplasias primarias (nuevos tipos de cáncer) en pacientes con mieloma múltiple de reciente diagnóstico, que tomaron Revlimid (lenalidomida).

Updated Questions and Answers for Healthcare Professionals and the Public: Use an Approved Pancreatic Enzyme Product (PEP)
Thu, 17 May 2012 07:56:00 -0500

FDA has updated questions and answers about the safe use of approved pancreatic enzyme products.

Newly Added Guidance Documents
Thu, 17 May 2012 07:36:00 -0500

Current Drug Shortages
Wed, 16 May 2012 10:58:00 -0500

New/Updated Drug Shortages: AsmanexTwisthaler, Isoniazid Tablets, Ketorolac Injection, Methylphenidate HCl, Nalbuphine HCl Injection, Odansetron Injection 2 mg/mL, Potassium Chloride Injection 2 mEq/mL, Thiotepa for Injection, Ticlopidine Tablets 5/16/2012

Drugs to be Discontinued
Wed, 16 May 2012 09:37:00 -0500

Drugs to be Discontinued: Digoxin Injection, Naltrexone Oral Tablets 5/16/2012

Generic Drugs: Information for Industry
Wed, 16 May 2012 09:15:00 -0500

News and Announcements updated

Medication Guides
Tue, 15 May 2012 10:57:00 -0500

Updated list of medication guides.

FDA Drug Safety Communication: Revised recommendations for cardiovascular monitoring and use of multiple sclerosis drug Gilenya (fingolimod)
Tue, 15 May 2012 09:24:00 -0500

The U.S. Food and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya (fingolimod). The agency also has evaluated additional clinical trial and postmarket data for Gilenya, including reports of patients who died of cardiovascular events or unknown causes.

National Drug Code Directory
Mon, 14 May 2012 09:14:00 -0500

FDA Drug Safety Communication: Safety review of a reported death after the first dose of Multiple Sclerosis drug Gilenya (fingolimod)
Mon, 14 May 2012 08:07:00 -0500

[12-20-2011] The U.S. Food and Drug Administration (FDA) has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod).

FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone
Thu, 10 May 2012 13:49:00 -0500

The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills

FDA Drug Safety Communication: Updated information on drug interactions between Victrelis (boceprevir) and certain boosted HIV protease inhibitor drugs
Thu, 10 May 2012 13:35:00 -0500

The U.S. Food and Drug Administration (FDA) is notifying the public that co-administration of Victrelis (boceprevir), a hepatitis C virus (HCV) protease inhibitor, along with certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors, is not recommended at this time because of the possibility of reducing the effectiveness of the medicines, permitting the amount of HCV or HIV virus in the blood (viral load) to increase.

FDA Drug Safety Communication: Planned return of CardioGen-82 to market with new Boxed Warning
Thu, 10 May 2012 13:28:00 -0500

[2-15-2012] The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals; in particular, the medical imaging community, about the planned return of CardioGen-82 to the U.S. market following the voluntary recall by the manufacturer, Bracco Diagnostics, Inc., on July 25, 2011.

FDA Drug Safety Communication: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies
Wed, 09 May 2012 07:24:00 -0500

The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide).

FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
Tue, 08 May 2012 10:18:00 -0500

[01-20-2012] The U.S. Food and Drug Administration (FDA) is informing the public that testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for progressive multifocal leukoencephalopathy (PML).

BMIS Zip Download File
Tue, 08 May 2012 10:08:00 -0500

File updated through 3/27/2012.

FDA Drug Safety Communication: Update: Preliminary findings from ongoing investigations of CardioGen-82
Tue, 08 May 2012 10:03:00 -0500

[1-12-2012] The U.S. Food and Drug Administration (FDA) is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82 on July 25, 2011 by the manufacturer, Bracco Diagnostics, Inc.

Pediatric Exclusivity Statistics
Tue, 08 May 2012 08:05:00 -0500

Updated list.

Written Requests Issued
Mon, 07 May 2012 14:07:00 -0500

Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies

What's New: Drugs RSS Feed

New and Generic Drug Approvals
Fri, 18 May 2012 14:33:00 -0500

Drug Approval Listing

Newly Added Guidance Documents
Thu, 17 May 2012 07:36:00 -0500

Drugs to be Discontinued
Wed, 16 May 2012 09:37:00 -0500

Drugs to be Discontinued: Digoxin Injection, Naltrexone Oral Tablets 5/16/2012

Generic Drugs: Information for Industry
Wed, 16 May 2012 09:15:00 -0500

News and Announcements updated

Medication Guides
Tue, 15 May 2012 10:57:00 -0500

Updated list of medication guides.

National Drug Code Directory
Mon, 14 May 2012 09:14:00 -0500

BMIS Zip Download File
Tue, 08 May 2012 10:08:00 -0500

File updated through 3/27/2012.

Pediatric Exclusivity Statistics
Tue, 08 May 2012 08:05:00 -0500

Updated list.

Written Requests Issued
Mon, 07 May 2012 14:07:00 -0500

Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies

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

Biologic Product Shortages
Thu, 10 May 2012 17:16:00 -0400

Complete List of Currently Approved NDA and ANDA Application Submissions
Tue, 08 May 2012 14:22:00 -0400

Information updated through April 30, 2012

Complete List of Currently Approved Premarket Approvals (PMAs)
Tue, 08 May 2012 14:21:00 -0400

Information updated through April 30, 2012

Complete List of Substantially Equivalent 510(k) Device Applications
Tue, 08 May 2012 14:19:00 -0400

Information updated through April 30, 2012

Jobs at the Center for Biologics Evaluation and Research (CBER)
Mon, 07 May 2012 15:20:00 -0400

Interdisciplinary Scientist, Closes: 4/23/2010; Supervisory Contract Specialist (Direct Hire), Closes: 12/31/2010

Cord Blood Banking Information for Consumers
Mon, 07 May 2012 14:15:00 -0400

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
Tue, 01 May 2012 08:53:00 -0400

Title 21 Code of Federal Regulations 640.120(a) - The Director, Center for Biologics Evaluation and Research, may approve an exception or alternative procedures to any requirement in subchapter F (Biologics) of Chapter I (Parts 600 - 680) of title 21 of the Code of Federal Regulations regarding blood, blood components or blood products. Both licensed and unlicensed blood establishments must submit requests for an exception or alternative procedure to the requirements in Parts 600-680.

List of Establishments Granted Approval for a Variance to 21CFR640.3(d) and 21CFR640.3(f)
Tue, 01 May 2012 07:51:00 -0400

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