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FDA’s Office of Manufacturing Quality will now be involved in evaluating all BLAs and supplements to ensure product quality throughout a product’s lifecycle. Read More
Drugmakers have just over a year to comply with new Canadian regulations requiring evidence of GMP compliance at foreign facilities that make active pharmaceutical ingredients. Read More
The FDA could issue guidance on demonstrating interchangeability between a biosimilar and its reference product by the end of the first quarter of next year. Read More
Drugmakers facing a European GMP inspection should be prepared to provide complete documentation of active ingredients throughout the supply chain, going back to the starting materials that were used in the synthesis of the APIs. Read More
The FDA is requiring Concordia Pharmaceuticals to conduct drug interaction studies with its potassium-lowering drug Kayexalate, after the agency’s review of just-approved Veltassa showed that drug bound to about half of the oral medications tested. Read More
The FDA should establish searchable names and correct incomplete entries in its inactive ingredient database to enhance its accuracy and usability, generic drug and excipients makers say. Read More
Drugmakers want the FDA to provide more details and examples of how it would show regulatory flexibility to developers of drugs for rare diseases, saying recent draft guidance is unclear about what may or may not be appropriate. Read More
The FDA hopes to cut down on patient-to-patient transmission of blood-borne infections by clearly labeling injectable therapies that are meant to be used multiple times by a single patient as products for “single-patient-use.” Read More