The QMN Weekly Bulletin

Manufacturers could see a stronger crackdown on off-label promotion according to a new Office of Inspector General (OIG) report directing HHS to focus on the practice.

Thoratec, a California-based maker of heart disease-treating equipment, failed to thoroughly investigate and submit a timely MDR for a complaint involving a patient’s death, according to a Form 483.

Clinical trial sponsors and sites have less than one month before the FDA begins enforcing a new rule that requires informed consent documents to include a specific statement that trial information will be made public on ClinicalTrials.gov, a new guidance states.

The FDA has informed Impax Laboratories that it is satisfied with the company’s efforts to address manufacturing violations at its Hayward, Calif., facility, but the agency has not closed out the matter because a final, required re-inspection of the plant has yet to occur.

California’s 2,000 biomedical companies face an extra layer of regulation: The state requires device and drug manufacturers to undergo an inspection by the California Department of Public Health’s Food and Drug Branch (CFDB) in addition to federally mandated FDA inspections.

The FDA and its EU and Australian counterparts have developed a blueprint for operating joint good manufacturing practice (GMP) inspections of active pharmaceutical ingredient (API) manufacturing facilities, the Australian Therapeutic Goods Administration (TGA) says.

Ongoing efforts to right GMP wrongs at Bedford Laboratories’ troubled Bedford, Ohio, plant have uncovered fresh manufacturing concerns that recently prompted three drug recalls — two for Ben Venue-marketed products and one for an injectable it produces under contract to Genzyme.

Drugmakers should voluntarily notify the FDA of product quality problems, manufacturing interruptions and delays in acquiring raw materials to help prevent drug shortages, the agency says in draft guidance issued Feb. 14.