We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA and EMA will expand their joint inspection activities to include facilities involved with bioequivalence studies for generic drug applications. Read More
The FDA has denied Public Citizen’s petition to withdraw prescription weight loss drug Xenical and its OTC equivalent Alli from the market, disagreeing with the government watchdog’s concerns that the products cause severe liver damage and offer few benefits. Read More
In a new enforcement initiative intended to boost drugmaker quality, the European Medicines Agency (EMA) has begun publishing the names of manufacturing facilities that fall out of compliance with good manufacturing practices (GMP). Read More
The FDA has extended by 60 days the comment period for its proposed safety labeling rule for generic drugs. Stakeholders now have until March 13 to comment on the proposal, which would allow generic drugmakers to update labels in response to safety issues without agency approval. Read More
The FDA is bringing the citizen petition process into the 21st century by allowing for electronic submissions, the agency says in a Federal Register notice published today. Read More
Pfizer will allow Teva to launch a generic of Viagra in the U.S. in 2017 — more than two years before the final patent on the drug expires — under a deal that settles a long-running patent flap. Read More
PhRMA is pushing back against the centerpiece of the FDA’s draft guidance on antibacterial drug development, saying superiority trials for antibacterials that treat drug-resistant infections are “neither routinely possible nor consistently ethical.” Read More
The European Medicines Agency (EMA) has indefinitely postponed a controversial plan to begin releasing to the public detailed information from clinical study reports contained in new drug applications, the central element to its clinical trial transparency initiative. Read More
HHS stands by its final rule expanding the discounts for orphan drugs that hospitals and healthcare providers can apply when used to treat non-rare diseases, the agency said in a court filing opposing PhRMA’s attempts to invalidate the rule. Read More
RSS
