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FDA Training PET Drug Plant Inspectors, Plans to Visit All Sites
Submitted by Correspondent on Sat, 02/04/2012 - 02:45The FDA is training a cadre of investigators to inspect positron emission tomography (PET) drug plants, and applicants with multiple sites can expect to see the FDA at all of their facilities.
Dr. Reddy’s Banking on Biosimilars to Boost Revenues
Submitted by Correspondent on Sat, 02/04/2012 - 02:45Like many drugmakers, Dr. Reddy’s Laboratories is looking to more complex products — particularly biosimilars — to drive future growth.
Glass Particle Prompts Bedford to Pull Lot of Overdose Drug
Submitted by Correspondent on Sat, 02/04/2012 - 02:45Ben Venue subsidiary Bedford Laboratories is voluntarily recalling one lot of its overdose drug acetylcysteine solution USP after finding a single glass particle in a 30 mL vial, the FDA says.
GMP Issues May Leave Two Roche Drugs in Short Supply
Submitted by Correspondent on Sat, 02/04/2012 - 02:45Roche may face shortages of its anemia treatment Mircera and weight-loss drug Xenical after discovering good manufacturing practice (GMP) shortfalls at its Florence, S.C., plant.
New Bill May Spur Separate Swift Approval Process for Chronic Illness Meds: Aides
Submitted by Correspondent on Fri, 02/03/2012 - 02:30A new bill intended to spur drugmaker interest in developing drugs for chronic illnesses may prompt creation of a distinct approval process for such treatments, congressional aides say.
New House Bill Tackles Drug Shortages Through Application Reviews, National Stockpile
Submitted by Correspondent on Fri, 02/03/2012 - 02:30Marketing applications for drugs in short supply could see expedited review under the Drug Shortage Prevention Act introduced in the House this week.
Big Pharma, Small Biotechs Face Off Over Accelerated Approval Changes
Submitted by Correspondent on Fri, 02/03/2012 - 02:30Money is at the center of a drug industry dispute on proposed changes to the accelerated approval process — a debate that has created a schism between large drugmakers and their smaller counterparts, an expert says.
OIG: HHS Must Clamp Down on Off-Label Promotion
Submitted by Correspondent on Fri, 02/03/2012 - 02:30Drugmakers could see a stronger crackdown on off-label promotion according to a new Office of Inspector General (OIG) report that directs HHS to focus on the practice.