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The European Medicines Agency said there is no evidence linking Novartis’ influenza vaccine Fluad to a series of adverse events and deaths that prompted Italian officials last month to suspend nearly a half-million doses of the product. Read More
The FDA is requiring drugmakers to revamp their product labeling to include clearer information on the safe use of drugs and biologicals in pregnant women and nursing mothers, marking the first labeling requirement of its kind since the late 1970s. Read More
Compounding pharmacies are warning that a federal drug safety law is starting to hamper their ability to supply needed therapies to patients, and that a strict reading of the law could cause even greater hurdles to producing the products. Read More
The FDA is considering a new inspection scoring system that would for the first time recognize drugmakers that go beyond normal compliance with good manufacturing practices. Read More
Manufacturers developing biosimilars in Europe want regulators to go back to comparing their therapies with the reference product, based on the actual amount of active ingredient in a dose, rather than a proposed standard that compares dosages and routes of administration. Read More
European regulators have granted Astellas’ oncology drug Xtandi a new indication for men with pre-chemotherapy prostate cancer who have failed androgen deprivation therapy, putting it in direct competition with Johnson & Johnson’s Zytiga. Read More
The FDA’s quality metrics collection program is facing delays as the agency expands it to include biologics manufacturers in addition to drugmakers. Read More
The FDA is expected to start training investigators next year on how to tell whether a facility’s quality culture is good or poor, a development that lays the groundwork for eventual scrutiny of this new indicator during inspections. Read More
India’s Central Drugs Standard Control Organization is seeking industry feedback on a draft of accreditation and ethics standards that it expects from clinical trial sites, investigators and ethics committees. Read More
The FDA has approved a new indication for Sanofi’s tuberculosis drug Priftin in combination with isoniazid to treat latent tuberculosis infection (LTBI). Read More