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Drugmakers are asking the European Commission to clarify new requirements for equipment used in the manufacturing process, including when it’s okay to test such equipment at the factory instead of on site. Read More
The label the FDA issued for Hetlioz omitted “in blind patients without light perception,” thus allowing anyone with Non-24 disorder to use the drug. Read More
Industry groups want the FDA to clarify its rules around manufacturer promotion of off-label drug use and are using the lawsuit to press their case. 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