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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 Updates Statement on the Investigation into the Salmonella Montevideo Outbreak
Thu, 04 Feb 2010 13:10:00 -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 Issues Guidance to Help Streamline Medical Device Clinical Trials
Fri, 05 Feb 2010 11:55:00 -0500

The U.S. Food and Drug Administration today issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies.

United States Seizes more than 1500 Cases of Food from Wisconsin Distribution Warehouse
Wed, 03 Feb 2010 17:21:00 -0500

At the request of the U.S. Food and Drug Administration, U.S. Marshals on Tuesday seized a wide range of human and animal food products stored under insanitary conditions at Mid-States Closeouts, a distribution warehouse in Ellsworth, Wis. The products were seized under a warrant issued by the U.S. District Court for the Western District of Wisconsin.

FDA Approves Xiaflex for Debilitating Hand Condition
Wed, 03 Feb 2010 08:55:00 -0500

The U.S. Food and Drug Administration today approved Xiaflex (collagenase clostridium histolyticum) as the first drug to treat a progressive hand disease known as Dupuytren's contracture, which can affect a person’s ability to straighten and properly use their fingers.

FDA Requests $4.03 Billion to Transform Food Safety System, Invest in Medical Product Safety, Regulatory Science
Mon, 01 Feb 2010 14:30:00 -0500

The U.S. Food and Drug Administration is requesting $4.03 billion to promote and protect public health as part of the President’s fiscal year 2011 budget – a 23 percent increase over the agency’s current $3.28 billion budget. The FY 2011 request, which covers the period of Oct.1, 2010, through Sept. 30, 2011, includes increases of $146 million in budget authority and $601 million in industry user fees.

FDA Announces Safety Risk Associated with HIV Drug
Mon, 01 Feb 2010 13:28:00 -0500

The U.S. Food and Drug Administration today announced that non-cirrhotic portal hypertension, a rare, but serious, liver disorder, has been reported in some HIV patients taking Videx/Videx EC (didanosine). Videx is an antiretroviral medicine first approved by the FDA in 1991. Videx EC is a delayed-release version of Videx approved in 2000. Videx/Videx EC is used in combination with other antiretroviral medicines to treat HIV infection in children and adults.

FDA Collaboration Seeks to Speed Development of Pneumococcal Vaccines for Children in Developing Countries
Mon, 01 Feb 2010 12:38:00 -0500

The U.S. Food and Drug Administration (FDA) today announced a collaboration with PATH to advance development of a vaccine to protect children against diseases caused by Streptococcus pneumoniae (pneumococcus), especially pneumonia. Worldwide, the bacterium also causes infections of the brain (meningitis), blood (sepsis), and middle ear (otitis media) and each year kills about 1 million children younger than 5 years of age. The collaboration aims to improve the techniques used to produce effective, safe, and affordable vaccines against pneumococcal disease for children in the developing world. PATH is an international nonprofit organization based in Seattle that creates sustainable, culturally relevant, and affordable solutions to help communities worldwide to break cycles of poor health. The collaborative project, expected to run for two years, is being conducted under the Cooperative Research and Development Agreement (CRADA) program. The program allows federal laboratories and businesses to form partnerships that help expedite research activities.

FDA Statement on the Investigation into the Salmonella Montevideo Outbreak
Fri, 29 Jan 2010 21:12:00 -0500

The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture, is working closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infection associated with certain salami products.

FDA Expands Use of Approved Breast Cancer Drug
Fri, 29 Jan 2010 18:35:00 -0500

The U.S. Food and Drug Administration today approved Tykerb (lapatinib) in combination with Femara (letrozole) to treat hormone positive and HER2-positive advanced breast cancer in postmenopausal women for whom hormonal therapy is indicated.

United States Seizes Unapproved Ozone Generators
Fri, 29 Jan 2010 14:47:00 -0500

At the request of the U.S. Food and Drug Administration, U.S. Marshals today seized 79 ozone generators, models AOS-1M and AOS-1MD, from Applied Ozone Systems of Auburn, Calif. The seized goods, which are medical devices, are valued at $75,900.

FDA Announces Class I Recall of Certain Infusion Set Needles
Tue, 26 Jan 2010 11:19:00 -0500

The U.S. Food and Drug Administration today announced a Class I recall of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets, manufactured by Nipro Medical Corporation for Exelint International Corporation.

FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain
Tue, 26 Jan 2010 10:41:00 -0500

The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.

FDA Approves New Treatment for Type 2 Diabetes
Mon, 25 Jan 2010 19:00:00 -0500

The U.S. Food and Drug Administration today approved Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults.

FDA Approves First Percutaneous Heart Valve
Mon, 25 Jan 2010 15:00:00 -0500

The U.S. Food and Drug Administration today approved the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System, the first heart valve to be implanted through a catheter, or tube, in a leg vein and guided up to the heart. This new approach to the treatment of adults and children with previously implanted, poorly functioning pulmonary valve conduits can delay the need for open-heart surgery.

FDA Schedules Public Meeting on Premarket Clearance Process for Medical Devices
Fri, 22 Jan 2010 17:25:00 -0500

The U.S. Food and Drug Administration announced today that it has scheduled a public meeting on Feb. 18, 2010, to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the United States. The FDA receives more than 3,000 510(k) submissions each year.

FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis
Fri, 22 Jan 2010 15:59:00 -0500

The U.S. Food and Drug Administration today approved Ampyra (dalfampridine) extended release tablets to improve walking in patients with multiple sclerosis (MS). In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with an inactive pill (placebo). This is the first drug approved for this use.

FDA Approves Left Ventricular Assist System for Severe Heart Failure Patients
Wed, 20 Jan 2010 16:09:00 -0500

The U.S. Food and Drug Administration today approved the HeartMate II, a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for heart transplantation.

U.S. Attorney New Release: Bellevue, Washington Salon Owner Sentenced in Connection with Unlicensed Cosmetic Treatments
Tue, 19 Jan 2010 12:47:00 -0500

According to testimony at trial and records filed in the case, FAITH HE used counterfeit Botox© and Restylane© on customers at her Bellevue beauty salon. FAITH HE was not a medical doctor licensed to use injectable treatments for wrinkle removal such as Botox and Restylane.

FDA Warns Consumers about Counterfeit Alli
Mon, 18 Jan 2010 09:44:00 -0500

The U.S. Food and Drug Administration is today warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)—the maker of the FDA approved over-the-counter weight-loss product— revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine. Sibutramine is a drug that should not be used in certain patient populations or without physician oversight. Sibutramine can also interact in a harmful way with other medications the consumer may be taking.

FDA Commissioner Addresses Nation's Health Care Professionals on H1N1 Vaccine Safety
Fri, 15 Jan 2010 15:59:00 -0500

FDA Commissioner Margaret A. Hamburg today sent a letter to America’s health care professionals thanking them for their efforts during the 2009 H1N1 influenza outbreak and providing information on safety monitoring of the 2009 H1N1 vaccines.

Food and Drug Administration--Recalls/Safety Alerts

Cousins Products, Llc, Issues An Allergy Alert On Undeclared Egg, Soy, And Wheat In Spinach Vinaigrette
Fri, 05 Feb 2010 08:56:00 -0500

Cousins Products, LLC, of Covington, LA is voluntarily recalling the following Spinach Vinaigrette in 16 oz. jars

Haifa Smoked Fish Inc. Issues An Allert On Uneviscerated Whole Schmaltz Herring
Thu, 04 Feb 2010 14:45:00 -0500

Haifa Smoked Fish, located in Queens, New York, is recalling Haifa brand vacuum packaged Whole Schmaltz Herring with the lot number 20, because the product was found to be uneviscerated.

Pierino Frozen Foods Inc. Issues an Allergy Alert on Undeclared Eggs in Its Jumbo Shells with Cheese
Wed, 03 Feb 2010 17:15:00 -0500

Pierino Frozen Foods Inc. of Lincoln Park, Michigan is recalling its 24 oz. packages of Pierino Frozen Foods’ “Jumbo Shells with Cheese” because they contain undeclared eggs. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products.

Global Commodities Inc. Issues Allergy Alert On Undeclared Sulfites In Aahu Barah Brand Dry Apricot
Tue, 02 Feb 2010 16:39:00 -0500

Global Commodities Inc. of Hicksville, NY is recalling its 0.50 lbs. packages of Aahu Barah brand Dry Apricot food treats because they contain undeclared Sulfites. People who have allergies to Sulfites run the risk of serious or life-threatening allergic reaction if they consume this product.

Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall
Thu, 28 Jan 2010 21:32:00 -0500

Plastic centrifuge rotor may crack, break apart and be forcefully ejected.

Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall
Tue, 26 Jan 2010 13:07:00 -0500

Class I recall due to "coring" or dislodging of silicone cores or slivers from the ports into which they are inserted.

Hettich Centrifuges Issues a North America and Canada Recall of Plastic Hematocrit Rotors
Fri, 22 Jan 2010 18:43:00 -0500

Hettich Centrifuges, Beverly, MA, is initiating a North America and Canada recall of 2050 and 2076 plastic hematocrit rotors that are used in combination with the Mikro 12- 24, Mikro 20, Haematokrit 20 and Haematokrit 24 bench top plastic centrifuges. These plastic rotors have the potential to break apart resulting in pieces of the rotor to be forcefully ejected through the plastic centrifuge housing.

Nipro Medical Corporation Issues a Voluntary Recall of All GlucoPro Insulin Syringes
Fri, 22 Jan 2010 14:05:00 -0500

Nipro Medical Corporation, Miami FL, is initiating a nationwide recall of all GlucoPro Insulin Syringes (This does not include the GlucoPro syringe specific for use with the Amigo Insulin pump). These syringes may have needles that detach from the syringe.

The Wisconsin Cheeseman® Recalls Cheese Logs/Cheese Balls
Thu, 21 Jan 2010 15:16:00 -0500

The Wisconsin Cheeseman® announced today that it is recalling cheese log/cheese ball products in conjunction with the voluntary recall initiated by Parkers Farm, Inc. on January 15, 2010. Parkers Farm, Inc., located in Coon Rapids, Minnesota, believes some of its food items have the potential to be contaminated with Listeria monocytogenes bacteria

Hines Nut Company Announces Recall of Pine Nuts Because of Possible Health Risk
Fri, 15 Jan 2010 16:30:00 -0500

Hines Nut Company has initiated a recall of 270 packages of Pine Nuts, packaged under the brand name Harris Teeter Farmers Market. The Pine Nuts were purchased from Red River Foods in Camarillo, CA, and have the potential to be contaminated with Salmonella.

MuscleMaster.com Conducts a Voluntary Nationwide Recall of Certain Body Building Products
Fri, 15 Jan 2010 16:15:00 -0500

MuscleMaster.com, Inc. (“MuscleMaster.com”) announced today that it is conducting a voluntary nationwide recall of all lots and expiration dates of the seventeen below listed dietary supplements sold between June 1, 2009 and November 17, 2009 (hereinafter "Recalled Products"). FDA informed MuscleMaster.com that it believes that the Recalled Products contain ingredients that are steroids. Specifically, FDA advised MuscleMaster.com of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol."

Parkers Farm, Inc. Expands Recall to Include All of Its Products, Regardless of Code Dates, Because of Possible Health Risk
Fri, 15 Jan 2010 15:59:00 -0500

PARKERS FARM, INC. OF COON RAPIDS, MINNESOTA TODAY EXPANDED THE PREVIOUSLY ANNOUNCED RECALL OF PRODUCTS TO INCLUDE ALL DATE CODES BECAUSE THEY HAVE THE POTENTIAL TO BE CONTAMINATED WITH LISTERIA MONOCYTOGENES, AN ORGANISM WHICH CAN CAUSE SERIOUS AND SOMETIMES FATAL INFECTION IN YOUNG CHILDREN, FRAIL OR ELDERLY PEOPLE, AND OTHERS WITH WEAKENED IMMUNE SYSTEMS. ALTHOUGH HEALTHY INDIVIDUALS MAY SUFFER ONLY SHORT-TERM SYMPOTMS SUCH AS HIGH FEVER, SEVERE HEADACHE, STIFFNESS, NAUSEA, ABDOMINAL PAIN AND DIARRHEA, LISTERIA INFECTION CAN CAUSE MISCARRIAGES AND STILLBIRTHS AMONG PREGNANT WOMEN.

PEO Chapter FO Recalls Roasted Hazelnuts Because of Possible Health Risk
Fri, 15 Jan 2010 15:35:00 -0500

PEO Chapter FO of Ashland, Oregon is recalling 75 - 1 lb packages of roasted hazelnuts, because they have the potential to 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. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.

McNeil Consumer Healthcare Announces Voluntary Recall of Certain Over-The-Counter (OTC) Products in the Americas, UAE, and Fiji
Fri, 15 Jan 2010 12:58:00 -0500

In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is voluntarily recalling certain lots of OTC products in the Americas, the United Arab Emirates (UAE), and Fiji (FULL RECALLED PRODUCT LIST BELOW). The company is initiating this recall following an investigation of consumer reports of an unusual moldy, musty, or mildew-like odor that, in a small number of cases, was associated with temporary and non-serious gastrointestinal events. These include nausea, stomach pain, vomiting, or diarrhea.

FDA Health Alert for Merrick Beef Filet Squares Dog Treats Packaged and Distributed by Merrick Pet Care
Thu, 14 Jan 2010 17:35:00 -0500

The U. S. Food and Drug Administration is warning consumers not to use Merrick Beef Filet Squares for dogs distributed by Merrick Pet Care with a package date of “Best By 111911” because the product may be contaminated with Salmonella.

HAPPYTOT Stage 4 and HAPPYBABY Stage 1 & Stage 2 Pouch Meals - Recall
Wed, 13 Jan 2010 19:07:00 -0500

Selected varieties recalled due to packaging defect that could cause possible bacterial contamination.

Nurture, Inc. Issues Voluntary Recall on select HAPPYTOT Stage 4 and HAPPYBABY Stage 1 & Stage 2 Pouch Meals Due to a Packaging Defect that could cause a Possible Bacterial Contamination
Wed, 13 Jan 2010 15:37:00 -0500

Nurture, Inc., is voluntarily recalling selected varieties and date codes of HAPPYTOT Stage 4 and HAPPYBABY Stage 1 and Stage 2 pouch meals with date codes expiring between November 2010 and January 2011. These products are being recalled due to a packaging defect that potentially could cause the pouches to swell or leak. Swollen or leaking pouches could indicate that the products may contain bacteria that could potentially cause illness.

Heluva Good Recalls Cold Pack Cheese Products Because of Possible Health Risk
Wed, 13 Jan 2010 11:04:00 -0500

HP Hood is recalling select Heluva Good branded 8 oz. plastic cup containers of Cold Pack Cheese Food because they may contain 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 and nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

Parkers Farm, Inc. Recalls Several Products Because of Possible Health Risk
Mon, 11 Jan 2010 17:50:00 -0500

PARKERS FARM, INC. OF COON RAPIDS, MINNESOTA IS RECALLING PRODUCTS BECAUSE THEY HAVE THE POTENTIAL TO BE CONTAMINATED WITH LISTERIA MONOCYTOGENES, AN ORGANISM WHICH CAN CAUSE SERIOUS AND SOMETIMES FATAL INFECTION IN YOUNG CHILDREN, FRAIL OR ELDERLY PEOPLE, AND OTHERS WITH WEAKENED IMMUNE SYSTEMS. ALTHOUGH HEALTHY INDIVIDUALS MAY SUFFER ONLY SHORT-TERM SYMPOTMS SUCH AS HIGH FEVER, SEVERE HEADACHE, STIFFNESS, NAUSEA, ABDOMINAL PAIN AND DIARRHEA, LISTERIA INFECTION CAN CAUSE MISCARRIAGES AND STILLBIRTHS AMONG PREGNANT WOMEN. NO ILLNESSES HAVE BEEN REPORTED TO DATE IN CONNECTION WITH THIS PROBLEM

What's New: Drugs RSS Feed

Questions and Answers for Healthcare Professionals: CRESTOR and the JUPITER Trial
Mon, 08 Feb 2010 17:34:00 -0500

FDA Drug Safety Communication: Risk of Progressive Multifocal Leukoencephalopathy (PML) with the use of Tysabri (natalizumab)
Fri, 05 Feb 2010 11:19:00 -0500

The U.S. Food and Drug Administration (FDA) is alerting the public that the risk of developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection associated with the use of Tysabri (natalizumab), increases with the number of Tysabri infusions received.

Current Drug Shortages
Fri, 05 Feb 2010 11:11:00 -0500

Current Drug Shortages: Indocin I. V. (indomethacin for injection) (updated) 2/5/2010, Neupro (rotigotine transdermal system)(updated) 2/5/2010, Pentothal (thiopental) Injection (updated) 2/5/2010, Methotrexate injection (updated) 2/5/2010, Vecuronium Injection (updated) 2/5/2010, Thiotepa 15mg injection (updated) 2/5/2010, Mitomycin for injection (updated) 2/5/2010, Acyclovir Tablets and Capsules (updated) 2/2/2010 Erythromycin Ophthalmic Ointment (updated) 1/26/2010, Technetium Tc99m Generators (updated) 1/20/2010, Octreoscan (Kit for the Preparation of Indium In 111 Pentetreotide) 1/10/2010

Contents of a Complete Submission for the Evaluation of Proprietary Names
Fri, 05 Feb 2010 06:38:00 -0500

Drugs@FDA Data Files
Thu, 04 Feb 2010 13:27:00 -0500

Data files updated through February 3, 2010.

Written Requests Issued
Thu, 04 Feb 2010 10:34:00 -0500

Updated list.

Pediatric Exclusivity Statistics
Thu, 04 Feb 2010 10:28:00 -0500

Updated list.

Drug Master Files (DMFs)
Thu, 04 Feb 2010 09:08:00 -0500

Files updated for 3rd Quarter 2009.

Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
Wed, 03 Feb 2010 11:50:00 -0500

The Orange Book lists drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act.

First-Time Generics - December 2009
Wed, 03 Feb 2010 11:24:00 -0500

ANDA (Generic) Drug Approvals
Wed, 03 Feb 2010 11:14:00 -0500

Updated listing.

Paragraph IV Patent Certifications
Wed, 03 Feb 2010 10:51:00 -0500

Updated list.

Warning Letters 2010
Wed, 03 Feb 2010 09:40:00 -0500

Letters added

FDA Technical Briefing on Its FY 2011 Budget Request
Fri, 29 Jan 2010 16:10:00 -0500

FDA Drug Safety Communication: Serious liver disorder associated with the use of Videx/Videx EC (didanosine)
Fri, 29 Jan 2010 13:12:00 -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).

National Drug Code Directory
Fri, 29 Jan 2010 08:20:00 -0500

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

Warning Letters 2009
Thu, 28 Jan 2010 13:30:00 -0500

Dr. Charles McKay, Hopewell, Eisai and Shire Warning Letters added

Information for Healthcare Professionals: Ceftriaxone (marketed as Rocephin and generics)
Thu, 28 Jan 2010 13:03:00 -0500

This Alert highlights important revisions to the Warnings, Dosage and Administration, Contraindications, and Clinical Pharmacology sections of the full prescribing information for ceftriaxone (Rocephin and its generics).

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)
Tue, 26 Jan 2010 11:49:00 -0500

Updated list.

Information for Healthcare Professionals: Cefepime (marketed as Maxipime)
Tue, 26 Jan 2010 11:41:00 -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.

What's New: Drugs RSS Feed

Questions and Answers for Healthcare Professionals: CRESTOR and the JUPITER Trial
Mon, 08 Feb 2010 17:34:00 -0500

Contents of a Complete Submission for the Evaluation of Proprietary Names
Fri, 05 Feb 2010 06:38:00 -0500

Drugs@FDA Data Files
Thu, 04 Feb 2010 13:27:00 -0500

Data files updated through February 3, 2010.

Written Requests Issued
Thu, 04 Feb 2010 10:34:00 -0500

Updated list.

Pediatric Exclusivity Statistics
Thu, 04 Feb 2010 10:28:00 -0500

Updated list.

Drug Master Files (DMFs)
Thu, 04 Feb 2010 09:08:00 -0500

Files updated for 3rd Quarter 2009.

First-Time Generics - December 2009
Wed, 03 Feb 2010 11:24:00 -0500

ANDA (Generic) Drug Approvals
Wed, 03 Feb 2010 11:14:00 -0500

Updated listing.

Paragraph IV Patent Certifications
Wed, 03 Feb 2010 10:51:00 -0500

Updated list.

Warning Letters 2010
Wed, 03 Feb 2010 09:40:00 -0500

Letters added

FDA Technical Briefing on Its FY 2011 Budget Request
Fri, 29 Jan 2010 16:10:00 -0500

National Drug Code Directory
Fri, 29 Jan 2010 08:20:00 -0500

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

Warning Letters 2009
Thu, 28 Jan 2010 13:30:00 -0500

Dr. Charles McKay, Hopewell, Eisai and Shire Warning Letters added

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

Zostavax
Wed, 22 Apr 2009 12:49:00 -0400

December 18, 2009 Approval Letter, Summary Basis for Regulatory Action, updated Package Insert and Patient Information to include the statement that Zostavax and Pneumovax 23 should not be given concurrently.

Biologic Product Shortages
Mon, 20 Oct 2008 16:45:00 -0400

Complete List of Substantially Equivalent 510(k) Device Applications
Sat, 09 May 2009 01:14:00 -0400

Information updated through January 31, 2010

Complete List of Currently Approved Premarket Approvals (PMAs)
Fri, 08 May 2009 22:33:00 -0400

Information updated through January 31, 2010

Complete List of Currently Approved NDA and ANDA Application Submissions
Fri, 08 May 2009 22:50:00 -0400

Information updated through January 31, 2010

Cord Blood Licensure: A Workshop
Wed, 27 Jan 2010 12:58:00 -0500

March 8 - 9, 2010

Influenza Virus Vaccine for the 2009-2010 Season
Thu, 28 May 2009 13:06:00 -0400

Vaccine lot release information updated on 1/20/2010.

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Questions and Answers
Wed, 13 Jan 2010 16:54:00 -0500

Field Correction of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Expiration Dating
Fri, 15 Jan 2010 14:49:00 -0500

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