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The FDA and the European Medicines Agency are working to increase regulatory collaboration, including harmonizing their respective pharmacovigilance and quality by design programs, officials from both agencies said Thursday. 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
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
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