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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 Inlyta to treat patients with a type of advanced kidney cancer
Fri, 27 Jan 2012 12:09:00 -0500

The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

Department of Justice files Consent Decree of Permanent injunction against Ranbaxy
Wed, 25 Jan 2012 16:59:00 -0500

Generic drug manufacturer agrees to remedy deviations from the current good manufacturing practice requirements and to correct data integrity problems at numerous facilities

Maine company holds cold smoked salmon product after FDA order
Tue, 24 Jan 2012 18:04:00 -0500

A Maine food processing and storage company destroyed its cold smoked salmon product under the supervision of the U.S. Food and Drug Administration after inspectors found Listeria monocytogenes within the firm’s facility and on processing equipment

FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri
Fri, 20 Jan 2012 15:21:00 -0500

Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD).

FDA approves Voraxaze to treat patients with toxic methotrexate levels
Tue, 17 Jan 2012 16:58:00 -0500

The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure. Methotrexate is a commonly used cancer chemotherapy drug normally eliminated from the body by the kidneys. However, patients receiving high doses of methotrexate may develop kidney failure.

FDA completes work on three drug user fee programs
Fri, 13 Jan 2012 12:37:00 -0500

The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said today. The recommendations were transmitted to Congress today by Health and Human Services Secretary Kathleen Sebelius.

FDA expands use of endovascular graft to treat aortic tears
Fri, 13 Jan 2012 15:59:00 -0500

The U.S. Food and Drug Administration today expanded the approved usage for an endovascular graft manufactured by W.L. Gore and Associates Inc. to include treatment of life-threatening tears or ruptures of the aorta (thoracic aortic transection). (MB)

FDA to protect important class of antimicrobial drugs for treating human illness
Wed, 04 Jan 2012 12:05:00 -0500

The U.S. Food and Drug Administration today issued an order that prohibits certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5, 2012.

FDA expands use of Prevnar 13 vaccine for people ages 50 and older
Fri, 30 Dec 2011 14:22:00 -0500

Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.

FDA to approve shared system REMS for TIRF products
Thu, 29 Dec 2011 13:38:00 -0500

The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products.

FDA: Chicago-area sandwich manufacturer agrees to stop production
Thu, 22 Dec 2011 15:08:00 -0500

The U.S. Food and Drug Administration announced today that a Chicago-area company has agreed to stop making its ready-to-eat sandwiches and produce after FDA investigators repeatedly found unsanitary conditions and bacterial contamination in the facility.

FDA expands use of HIV drug Isentress to children and adolescents
Wed, 21 Dec 2011 12:52:00 -0500

Isentress (raltegravir) was approved today by the U.S. Food and Drug Administration for use with other antiretroviral drugs for the treatment of HIV-1 infection for children and adolescents ages 2-18.

FDA: Do not use ShoulderFlex Massager
Wed, 21 Dec 2011 11:57:00 -0500

The U.S. Food and Drug Administration is warning consumers again not to use the ShoulderFlex Massager, imported by King International and sold by various companies, due to serious potential health risks.

FDA collaboration to monitor rare eye condition associated with cataract surgery
Tue, 20 Dec 2011 10:18:00 -0500

The U.S. Food and Drug Administration and other government and professional organizations today unveiled a program to monitor medical devices used in cataract surgery in an effort to stem outbreaks of a rare, inflammatory condition associated with the procedure.

FDA approves mechanical cardiac assist device for children with heart failure
Fri, 16 Dec 2011 11:38:00 -0500

The U.S. Food and Drug Administration today approved a medical device that supports the weakened heart of children with heart failure to help keep them alive until a donor for a heart transplant can be found. The mechanical pulsatile cardiac assist device is called the EXCOR Pediatric System, made by a German company, Berlin Heart. The device comes in graduated sizes to fit children from newborns to teens.

FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies
Fri, 16 Dec 2011 09:12:00 -0500

Draft guidance aimed to address the historic underrepresentation of women in clinical studies was issued by the U.S. Food and Drug Administration today. Intended for medical device developers and manufacturers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.

FDA Statement on the Institute of Medicine Report: Scientific Standards for Studies on Modified Risk Tobacco Products
Wed, 14 Dec 2011 11:41:00 -0500

Today, the Institute of Medicine released a report on the design and conduct of studies which the FDA will take into consideration in the assessment and ongoing review of modified risk tobacco products. A modified risk tobacco product is any tobacco product sold or distributed for use to lower the harm or risk of tobacco-related disease associated with other tobacco products.

FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull
Tue, 13 Dec 2011 14:32:00 -0500

The U.S. Food and Drug Administration today allowed marketing of the first hand-held device intended to aid in the detection of life-threatening bleeding in the skull called intracranial hematomas, using near-infrared spectroscopy.

FDA issues Warning Letters for misleading advertising of Lap-Band
Tue, 13 Dec 2011 11:01:00 -0500

The U.S. Food and Drug Administration today announced that it has taken action against eight California surgical centers and the marketing firm 1-800-GET-THIN LLC, for misleading advertising of the Lap-Band, an FDA-approved device used for weight loss in obese adults.

Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step
Wed, 07 Dec 2011 12:18:00 -0500

Food and Drug Administration--Recalls/Safety Alerts

Pinnacle Foods Group LLC Issues Allergy Alert On Undeclared Soy Protein In Aunt Jemima Frozen Pancakes
Fri, 27 Jan 2012 21:37:00 -0500

Out of regard and concern for our consumers, Pinnacle Foods Group LLC is recalling certain Aunt Jemima Frozen Pancakes. The product may contain soy protein, an undeclared allergen.

Cephalon, Inc. issues a voluntary nationwide recall of TreandaÂ® (bendamustine HCL) for Injection 25mg/Vial Due to Particulate Matter
Fri, 27 Jan 2012 16:00:00 -0500

Cephalon, Inc. is voluntarily recalling TreandaÂ® (bendamustine HCL) for Injection 25mg/8mL; lot TB30111, expiration date 12/2012.Â This product lot is being recalled due to the presence of particulate matter found in a single vial, which has been identified as glass fragments

M.E. Thompson, Inc. Recalls Anytime Deli Brand Turkey & Ham Footlong Sandwich Because Of Possible Health Risk
Thu, 26 Jan 2012 10:10:00 -0500

M.E. Thompson, Inc. of Jacksonville, FL is recalling its Anytime Deli Turkey & Ham Sub Sandwich, UPC 0543200194, with an expiration date of January 19th and January 22nd 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 infection can cause miscarriages and stillbirths among pregnant women.

Jones' Seasoning Voluntarily Recalls Original and Spicy Southwest Blend Mock Salt Because of Possible Health Risk
Mon, 23 Jan 2012 18:07:00 -0500

University Place, Washington- Jones' Seasoning Blends LLC announced a voluntary recall of Jones' Mock Salt Original as well as Jones' Mock Salt Spicy Southwest Blend due to the potential contamination of Salmonella.

Price Chopper Supermarkets Recalls Shredded Taco Cheese
Fri, 20 Jan 2012 15:58:00 -0500

Price Chopper Supermarkets is issuing a voluntary recall on its Coyote Joes Shredded Taco Cheese 16 oz, UPC 41735-12509 with an expiration date of April 21, 2012 due to the possibility of shredded plastic fragments inside the packaging.

Perfect Image Solutions, LLC Issues Voluntary Recall of Unapproved Product Due to Potential Health Risk
Fri, 20 Jan 2012 12:48:00 -0500

Perfect Image Solutions, LLC is voluntarily recalling all lots of Men's Minoxidil 15% Azelaic 5% Hair regrowth topical, 60mL; Men's Minoxidil 10% Azelaic 5% Hair regrowth topical, 60mL; Men's Minoxidil 5% Azelaic 5% Hair regrowth topical, 60mL; Women's Minoxidil 3% Azelaic 5% Hair regrowth topical, 60mL; and Hair regrowth shampoo enhanced with Ketoconazole and salicylic acid, 180mL, to the consumer level. The products are deemed unapproved new drugs under the law and U.S. Food and Drug Administration regulations and may present potential health hazards.

Carefusion Provides Update on Voluntary Recall of Neurilogical Monitoring Software and Devices
Fri, 20 Jan 2012 12:16:00 -0500

CareFusion issued the following update regarding its voluntary recall of the Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License. The FDA has classified this action as a Class I recall.

JKS Wholesale SVCS, Allergy Alert On Undeclared Milk Allergens In Torta de Pan Date Code 02/15/2012
Fri, 20 Jan 2012 10:18:00 -0500

JKS Wholesale SVCS INC, of Beltsville, MD is recalling its 16 oz. packages of Torta de Pan because they may contain undeclared milk allergens. People who have allergies to milk run the risk of serious or life-threatening allergic reaction if they consume this product.

Kradjian Imp Co Is Doing An Expanded Recall Of Cedar Tree Brand Tresse Cheese And Cedar Tree Brand Shinglish Cheese Because Of Possible Health Risk
Thu, 19 Jan 2012 22:07:00 -0500

Kradjian Imp Co, Glendale, CA is recalling 231 Cases, 22Lb / Cs of Cedar Tree brand Tresse Cheese, 16 oz and Cedar Tree brand Shinglish cheese, 16 oz because they have 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 infection can cause miscarriages and stillbirths among pregnant women.

Rich Products Corporation expanded its voluntary recall on January 12, 2012, of Vanilla Pre-Soaked Sponge Cake to include the 8Ã¢â‚¬ï¿½ Vanilla Flavored Pre-Soaked Sponge Cake Artificially Flavored
Thu, 19 Jan 2012 18:15:00 -0500

Last week, Rich Products Corporation expanded its January 5, 2012 recall of one fourth Sheet Vanilla Soaked Sponge Cake Artificially Flavored to include the 8 inch Vanilla Flavored Pre-Soaked Sponge Cake Artificially Flavored (Product Code: 62938) because of the possibility that small plastic fragments from the packaging were contaminating the product.

USA Far Ocean Group Inc. Issues Voluntary Nationwide Recall of Vagifresh Ball and Vagifresh Gel, Marketed Individually or Under a Mixed Package Named Female One
Thu, 19 Jan 2012 16:58:00 -0500

USA Far Ocean Group Inc. (U.S.A. Far Ocean), is voluntarily recalling the Company's two products sold as cosmetic under the names Vagifresh BallÃƒâ€šÃ‚Â and Vagifresh Gel. These two products were also sold under the mixed package named Female One, which contained Vagifresh Ball, Vagifresh Gel and Vagifresh Liquid (this recall does not involve Vagifresh Liquid).

Winn-Dixie Issues Voluntary Recall On LEASA Brand Sprouts Due To Potential Salmonella Exposure
Thu, 19 Jan 2012 12:15:00 -0500

Winn-Dixie Stores, Inc., today announced an immediate Class I voluntary recall of all LEASA Living Alfalfa Sprouts sold in the 6 oz. package with a UPC code of 7546555912. According to the Federal Drug Administration (FDA), the product is potentially contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

LEASA Industries Co., Inc. Recalls LEASA Brand 6 oz. Living Alfalfa Sprouts Because Of Possible Health Risk
Thu, 19 Jan 2012 10:34:00 -0500

LEASA Industries Co., Inc. of Miami, FL is recalling 346 cases of LEASA Living Alfalfa Sprouts with use by date 2/1/12, 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.

Covidien Contraindicates the Use of Duet TRS for Thoracic Surgery, Implements a Voluntary Recall
Wed, 18 Jan 2012 11:37:00 -0500

Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that it is conducting a voluntary recall of all production lots for the Duet TRS Universal Straight and Articulating Single Use Loading Units, with respect to the use of this product family in the thoracic cavity.

Rexall Issues Allergy Alert on Undeclared Shellfish in Calcium 1200mg plus Vitamin D 1000 IU Softgels
Mon, 16 Jan 2012 20:08:00 -0500

Today Rexall, Inc., of Deerfield Beach, Florida, announced a recall of Rexall Calcium 1200 mg plus 1000IU Vitamin D3, 60 softgels. The affected bottles actually contain a TABLET product, Triple Strength Glucosamine Chondroitin and MSM Tablets.

Price Chopper Supermarkets Issues Voluntary Stuffed Clam Recall
Fri, 13 Jan 2012 18:53:00 -0500

Price Chopper Supermarkets is issuing a voluntary recall on 'Gourmet Stuffed Clams' from its seafood departments with a scale code of 209181. This product is being recalled due to the fact that it contains milk, wheat and eggs, three known allergens, which are not listed on the store generated ingredient label.

Price Chopper Supermarkets Recalls Tres Leches Cakes
Fri, 13 Jan 2012 17:27:00 -0500

Price Chopper Supermarkets is issuing a voluntary recall on two sizes of its bakery’s Central Market Classics Tres Leches cakes - the 5 inch, UPC 41735-26013, and the 8 inch, UPC 41735-25128. Rich Foods, the manufacturer of the cake layers contained in this product, has notified Price Chopper that they may contain plastic fragments.

Minnesota Firm Issues Recall Due to Undeclared Soy Allergen in Certain Sunflower Seeds
Fri, 13 Jan 2012 16:51:00 -0500

Ryt-way Industries LLC is voluntarily recalling select sunflower seeds because they may contain soy ingredients that were not declared on the packaging.Â The recall is being issued on BIGS Â® Dill Pickle Sunflower Seeds packaged in 5.35oz plastic bags with BEST BY Dates of 08DEC2012 and 09DEC2012 with an individual bag UPC code 896887002202.Â

Herbadashery LLC Issues Allergy Alert on Undeclared Anchovy in Pine Ridge BBQ and Dipping Sauce and Pine Ridge Jalapeño BBQ and Dipping Sauce
Fri, 13 Jan 2012 14:00:00 -0500

Herbadashery LLC, Casper, WY is recalling bottles of Pine Ridge BBQ and Dipping Sauce and Pine Ridge Jalapeño BBQ and Dipping Sauce manufactured after January 1, 2011 because they contain undeclared anchovies in the Worcestershire sauce used in production.

Gilster-Mary Lee, Corp. Announces Recall Of Hill Country Fare Brand Of Lasagna Dinner Mix Due To The Presence Of Undeclared Soy
Thu, 12 Jan 2012 17:06:00 -0500

Gilster-Mary Lee of Chester, IL is recalling some packages of dry lasagna dinner mix. The only brand involved is Hill Country Fare 6.4 oz. Lasagna Dinner which has a Best By date of NOV 21 12 Y18. (UPC# 41220-78102) Consumers should return to store for full refund.

What's New: Drugs RSS Feed

New and Generic Drug Approvals
Fri, 27 Jan 2012 16:55:00 -0500

Drug Approval Listing

Newly Added Guidance Documents
Fri, 27 Jan 2012 11:36:00 -0500

Current Drug Shortages
Fri, 27 Jan 2012 10:53:00 -0500

New/Updated Drug Shortages: Alfentanil Injection, Aminocaproic Acid, Bleomycin Injection, Bupivacaine Hydrochloride Injection, Butorphanol Injection, Fentanyl Citrate Injection, Furosemide Injection, Ketorolac Injection, Methotrexate Injection, Metoclopramide injection, Midazolam Injection, Paclitaxel Injection 1/27/2012

Drugs@FDA Data Files
Wed, 25 Jan 2012 15:36:00 -0500

Data files updated through January 11, 2012.

Warning Letters 2011
Wed, 25 Jan 2012 13:13:00 -0500

Letters added

FDA Drug Safety Communication: New risk factor for Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
Wed, 25 Jan 2012 10:09:00 -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).

Orange Book Zip File
Tue, 24 Jan 2012 13:17:00 -0500

December 2011 Orange Book data files, zip format.

Breakdown of FDAAA Completed Pediatric Studies
Fri, 20 Jan 2012 15:45:00 -0500

(updated)

FDA Drug Safety Communication: Safety update on Progressive Multifocal Leukoencephalopathy (PML) associated with Tysabri (natalizumab)
Fri, 20 Jan 2012 10:35:00 -0500

[04-22-2011] The U.S. Food and Drug Administration (FDA) continues to evaluate the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of Tysabri (natalizumab) for the treatment of multiple sclerosis (MS) and Crohn's disease.

National Drug Code Directory
Fri, 20 Jan 2012 10:32:00 -0500

NEW VERSION, 2.0: The National Drug Code Directory has been updated with data through January 18, 2012.

Orange Book Current Cumulative Supplement
Fri, 20 Jan 2012 07:31:00 -0500

December 2011 Cumulative Supplement

Inactive Ingredients Database Download
Wed, 18 Jan 2012 13:38:00 -0500

Data updated through December 31, 2011.

Additions/Deletions for Prescription and OTC Drug Product Lists
Tue, 17 Jan 2012 14:47:00 -0500

The list has been updated through September 2010.

Medication Guides
Tue, 17 Jan 2012 14:03:00 -0500

Updated list of medication guides.

FDA Drug Safety Communication: Updated information about the FDA-funded study on risk of blood clots in women taking birth control pills containing drospirenone
Tue, 17 Jan 2012 07:01:00 -0500

[10-27-2011] The U.S. Food and Drug Administration (FDA) is continuing its review of the potential increased risk of blood clots with the use of birth control pills containing drospirenone.

FDA Drug Safety Communication: New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin)
Fri, 13 Jan 2012 12:08:00 -0500

[1-13-2012] The U.S. Food and Drug Administration (FDA) is notifying the public that two additional cases of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris (brentuximab vedotin).

FDA Drug Safety Communication: Update: Preliminary findings from ongoing investigations of CardioGen-82
Thu, 12 Jan 2012 15:12:00 -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.

Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS)
Wed, 11 Jan 2012 19:01:00 -0500

One new report (July to September 2011) and eight updated reports

Generic Drugs: Information for Industry
Wed, 11 Jan 2012 09:04:00 -0500

News and Announcements updated

FDA Drug Safety Communication: Liver injury warning to be removed from Letairis (ambrisentan) tablets
Tue, 10 Jan 2012 14:39:00 -0500

The U.S. Food and Drug Administration (FDA) is removing the warning related to liver injury from the boxed warning of the Letairis (ambrisentan) tablet label.

What's New: Drugs RSS Feed

New and Generic Drug Approvals
Fri, 27 Jan 2012 16:55:00 -0500

Drug Approval Listing

Newly Added Guidance Documents
Fri, 27 Jan 2012 11:36:00 -0500

Drugs@FDA Data Files
Wed, 25 Jan 2012 15:36:00 -0500

Data files updated through January 11, 2012.

Warning Letters 2011
Wed, 25 Jan 2012 13:13:00 -0500

Letters added

Orange Book Zip File
Tue, 24 Jan 2012 13:17:00 -0500

December 2011 Orange Book data files, zip format.

Breakdown of FDAAA Completed Pediatric Studies
Fri, 20 Jan 2012 15:45:00 -0500

(updated)

National Drug Code Directory
Fri, 20 Jan 2012 10:32:00 -0500

NEW VERSION, 2.0: The National Drug Code Directory has been updated with data through January 18, 2012.

Orange Book Current Cumulative Supplement
Fri, 20 Jan 2012 07:31:00 -0500

December 2011 Cumulative Supplement

Inactive Ingredients Database Download
Wed, 18 Jan 2012 13:38:00 -0500

Data updated through December 31, 2011.

Additions/Deletions for Prescription and OTC Drug Product Lists
Tue, 17 Jan 2012 14:47:00 -0500

The list has been updated through September 2010.

Medication Guides
Tue, 17 Jan 2012 14:03:00 -0500

Updated list of medication guides.

Generic Drugs: Information for Industry
Wed, 11 Jan 2012 09:04:00 -0500

News and Announcements updated

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

Jobs at the Center for Biologics Evaluation and Research (CBER)
Tue, 24 Jan 2012 10:18:00 -0500

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

Complete List of Currently Approved NDA and ANDA Application Submissions
Mon, 09 Jan 2012 11:55:00 -0500

Information updated through December 31, 2011

Complete List of Currently Approved Premarket Approvals (PMAs)
Mon, 09 Jan 2012 11:53:00 -0500

Information updated through December 31, 2011

Complete List of Substantially Equivalent 510(k) Device Applications
Mon, 09 Jan 2012 11:51:00 -0500

Information updated through December 31, 2011

Clinical Investigator Status (Biologics)
Mon, 09 Jan 2012 07:12:00 -0500

Clinical Investigator Inspection List updated through 3/11/2010.

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
Thu, 29 Dec 2011 12:54:00 -0500

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.

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