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The World Health Organization (WHO) invited comments on a draft question-and-answer document that aims to clarify its 2009 guidelines on the evaluation of biosimilars. Read More
The company said it continues to believe the drug-device combination “could bring value to the management of pain and will assess the next steps in the context of the company’s overall mission.” Read More
The FDA released its BsUFA II fees for FY 2019, lowering biological product development fees from the fiscal 2018 rates while leaving application and program fees unchanged. Read More
The House Energy & Commerce Committee has called on the Federal Trade Commission to “closely analyze” recent mergers by pharmacy benefit managers to assess the impact on prescription drug prices. Read More
For all NDAs containing already approved active moieties, CDER’s pharmacology/toxicology reviewer must check the established pharmacologic class text phrases proposed for the product’s “indications and usage” section. Read More