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The FDA is taking steps toward getting more patient input during the drug development process, a move that puts the agency more in line with its EU counterparts, agency officials said Thursday at the DIA annual meeting. Read More
The U.S. Court of Appeals for the Federal Circuit has affirmed a lower court ruling that Celgene did not infringe on a Teva subsidiary’s patent when it marketed its cancer drug Abraxane. Read More
The FDA wants generics makers to design tablets and capsules to be similar in size and shape to their reference listed drug to ensure patient acceptance and compliance, according to final guidance issued Thursday. Read More
Merck & Co. has agreed to pay $5.9 million to settle a federal lawsuit claiming a former subsidiary promoted its pink eye drug for off-label uses. Read More
Just as the FDA is ramping up inspections in China, Chinese regulators are increasing their oversight of overseas manufacturing operations, conducting 30 inspections so far in 2015. Read More
The FDA should implement a pharmacovigilance audit program for drugmakers like the one the EMA adopted in 2012, to reduce the risk of postmarketing adverse events, a quality expert says. Read More
Drugmakers and patients can now access risk evaluation and mitigation strategies for FDA-approved drugs, thanks to an updated website launched by the FDA on Wednesday. Read More
Botox maker Allergan is broadening its aesthetics portfolio with the $2.1 billion purchase of Kythera Biopharmaceuticals, a company that produces drugs to battle double chins and male-pattern baldness. Read More
A federal judge says the FDA did not unlawfully decide to delay final approval of Veloxis Pharmaceuticals’ extended-release immunosuppression drug Envarsus. Read More
The FDA expects to boost its China office staff to 35 within the next two years and its India staff to 23 as the agency focuses on increasing inspections in both countries. Read More
The Office of Pharmaceutical Quality’s “One Quality Voice” is “well on its way to becoming a reality,” CDER Director Janet Woodcock said Tuesday. Read More