March 2011 | Full Issue in PDF Format
FDA officials are seeking industry input on a track and trace system for prescription drugs that would make it easier to identify counterfeit and other substandard products and provide accountability for the movement of drugs throughout the supply chain.
Sens. Olympia Snowe (R-Maine) and Debbie Stabenow (D-Mich.) have introduced the Pharmaceutical Market Access and Drug Safety Act of 2011, which would enhance the FDA’s ability to inspect foreign manufacturing plants and allow for the reimportation of prescription drugs.
Minnesota pharmaceutical company Upsher-Smith Laboratories is expanding a February recall of its anticoagulant Jantoven following a bottling mix-up at a plant.
Johnson & Johnson (J&J) can’t seem to shake its manufacturing woes as it announced three different recalls in February.
A group of Republican congressmen who have repeatedly chided the FDA for its handling of the 2007 Chinese tainted heparin crisis are opening a formal investigation into the issue now that they have a majority in the House.
Generic giant Teva Pharmaceutical is making equipment changes and adding new metal-detection equipment following a Form 483 received late last year.
FDA inspectors made eight observations at an Antigen Laboratories plant, including a failure to sufficiently clean stainless steel holding tanks after sterilization operations, a recent Form 483 notes.
FDA inspectors made two observations during a Dec. 8 to Dec. 15, 2010, inspection of active pharmaceutical ingredient (API) manufacturer Cayman Chemical, according to a Form 483.
Less than two weeks after Sanofi-Aventis received a sternly written warning letter from the FDA regarding adverse event reporting, the agency handed the company another warning letter for cGMP violations.
The FDA has blocked all imports from an Indian active pharmaceutical ingredients (API) manufacturer that supplies products to Pfizer and other U.S. pharmaceutical companies.
New legislation introduced in the Senate would require drugmakers to notify the FDA six months in advance of discontinuing, interrupting or adjusting the manufacture of “medically necessary” prescription drugs in order to avert shortages that could compromise patient care.
American Regent and Qualitest Pharmaceuticals have issued voluntary recalls of several products following errors during the drugs’ manufacturing processes.
Teva Pharmaceutical Industries has not provided the FDA with convincing evidence that problems related to the investigation of failed batches of drugs and other issues have been adequately addressed at a Jerusalem plant, the agency says in a warning letter.
OTC contract manufacturer Hawkeye-Jensen has not taken sufficient corrective actions in regards to current GMP violations, some of which date back to 2000, according to an FDA warning letter.
Dietary supplement maker Biotab Nutraceuticals voluntarily recalled two lots of a sexual enhancement tablet after the FDA found a counterfeit product contained active pharmaceutical ingredients (APIs) that could be dangerous to users.
The FDA has warned Scientific Protein Laboratories (SPL) that it could face legal action if it does not immediately correct a series of GMP violations cited during a July 28 to Sept. 3 inspection of its Waunakee, Wis., manufacturing plant.
The pharmaceutical industry’s growing trend of developing biologics and other complex therapies will require vast changes in manufacturing and distribution methods, according to a new report from PricewaterhouseCoopers (PwC).
Drugmakers nervous about seeing their executives targeted for criminal prosecution under the FDA’s stepped-up enforcement campaign based on the Park doctrine have received some insight into the factors the agency considers when pursuing such cases.
ePublishing :: CMS, Hosting & Web Development | © Copyright by FDAnewsAll rights reserved. Do not duplicate or redistribute in any form.