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Drugmakers are challenging the legality of FDA final guidance, calling for the design of generic tablets and capsules to be similar in size and shape to the reference drug to ensure patient acceptance. Read More
President Barack Obama on Sept. 15 nominated Robert Califf as the next FDA commissioner, capping a swift rise for the respected clinical researcher, who assumed the agency’s number two role — deputy commissioner for tobacco and medical products — in March. Read More
CDER Director Janet Woodcock came under fire Sept. 17 from senators demanding to know why the FDA is years behind Europe and Canada in establishing a workable program for biosimilars. Read More
Amneal Pharmaceuticals can begin marketing its generics version of Allergan’s Alzheimer’s extended-release drug Namenda XR on Jan. 31, 2020, pending FDA approval, under an agreement reached by the two firms. Read More
Two U.S. senators are renewing efforts to crack down on pay-for-delay pharmaceutical deals, reintroducing the Preserve Access to Affordable Generics Act on Sept. 9. Read More
The FDA is clarifying when drugmakers can seek dispute resolution above the divisional level, citing five regulatory actions that are appropriate for a formal dispute resolution request. Read More
Despite industry concerns that ICH’s proposed new limits on metals are too strict, the organization released final guidance on elemental impurities in finished drugs that appears little changed from an earlier draft. Read More
The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including specified timelines for deciding applications and increased public access to applications and information. Read More
Leaders of the House Energy & Commerce Committee are asking FDA Acting Commissioner Stephen Ostroff to explain what steps the agency is taking to address safety concerns around the blood thinner warfarin and its reference product, Coumadin. Read More
Impax Laboratories says the FDA has inspected its Hayward, Calif. manufacturing plant and cleared it of all issues raised in a 2011 warning letter, paving the way for the launch of new drug products. Read More