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Over the past week, the FDA issued final guidance on informed consent and premarket notification for magnetic resonance devices and extended the comment period for a draft guidance on demonstrating bioequivalence for type A medicated articles containing certain active pharmaceutical ingredient(s). Read More
The FDA requested that AstraZeneca devise a comprehensive plan of action to “disseminate truthful, non-misleading and complete” corrective communication. Read More
A biotech in Friday Harbor, Wash., has been warned by the FDA for failing to report the findings of a phase 2 trial of a combination product for relieving lower urinary tract symptoms caused by benign prostatic hyperplasia. Read More
After nine years in draft form and 127 comments received from stakeholders, the FDA has finalized its guidance on informed consent, adding a question-and-answer section that addresses specific issues. Read More
A federal appeals court has taken action to allow the abortion medication Mifeprex and its mifepristone generic forms to stay on the market, with the same restrictions that existed before FDA loosened prescribing requirements in 2016. Read More
Beyond the regulatory requirement to perform them, regular internal audits can benefit quality, productivity and an organization’s bottom line. But if you’re simply going through the motions of an internal audit to check that regulatory box or if you’re not properly analyzing the data that comes out of those audits, you’re missing a real opportunity, says quality expert says Steven Lynn, executive vice president of pharmaceuticals at Regulatory Compliance Associates. Read More
The FDA has reprimanded AstraZeneca for making false and misleading claims about its chronic lung inflammatory inhalation therapy Breztri Aerosphere (budesonide, glycopyrrolate and formoterol fumarate), while the agency has also smacked Denison, CalmCo and ALVA-AMCO Pharmaceutical Companies for selling unapproved drugs and good manufacturing practice (GMP) violations. Read More
A July 10-20 FDA inspection of a Biocon manufacturing facility in Malaysia turned up eight observations including a repeat observation of failure to follow procedures that prevent microbiological contamination of drugs intended to be sterile, and inadequate review and investigation of failed batches. Read More
Upcoming events in the coming weeks include seven FDA advisory committee meetings as well as the the GMP Quality Management vSummit, the WCG MAGI@Home Clinical Research Conference 2023, and a webinar from FDAnews, a WCG company on medical device risk management tools. Read More
Amgen and Horizon have launched a return volley in their battle with the FTC, asking the U.S. District Court of Northern Illinois to deny the FTC’s July motion that sought to strike down arguments that Amgen and Horizon’s constitutional defenses are legitimate considerations in the case. Read More