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Sponsors designing clinical trials that involve certain vulnerable patient populations will soon face greater scrutiny from institutional review boards, under newly issued FDA guidance. Read More
Indian regulators have issued a uniform set of procedures that state drug authorities should follow when inspecting plants for good manufacturing practices and issuing certificates of pharmaceutical product (COPP) that clear drugs for export. Read More
The FDA has expanded its list of priority generics applications to include ANDAs filed under government purchasing programs and applications from filers who claim “extraordinary hardship,” such as catastrophic incidents or abrupt supply disruption. Read More
Drugmakers Hoffman-La Roche and Hyperion Therapeutics are taking part in Health Canada’s new orphan drugs pilot project to better understand how patient input may be gathered and incorporated into the drug submission review process. Read More
Pfizer will pay $35 million divided among 41 states and the District of Columbia to settle allegations it improperly marketed its immunosuppressant Rapamune for unapproved uses, a year after making a $490.9 million deal with the federal government for similar allegations. Read More
Generics manufacturers seeking product approvals in the European Union can opt to share the resulting application reviews with regulatory bodies outside the bloc under a pilot program designed to coordinate drug approvals across international borders. Read More
The FDA has approved The Medicines Company’s intravenous skin disease treatment Orbactiv, the third such product cleared this year under a pathway that provides manufacturers incentives to develop new antibiotics for serious or life-threatening infections. Read More
Over the next four years, the FDA plans to increasingly coordinate its inspections and enforcement activities with its international counterparts. Read More
British regulators are seeking industry input to create a “white list” of prescription drugs that should be exempt from an EU requirement to verify the authenticity of products, as well as a “black list” of nonprescription drugs that must bear the verification. Read More
Cubist Pharmaceuticals recalled 101 lots of its antibiotic Cubicin because of a long-standing supplier issue that could have resulted in glass particles in vials. Read More