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The FDA can exercise flexibility on the quality manufacturing information it requires drugmakers to present under expedited drug approval processes, says a final guidance. Read More
The European Medicines Agency is considering new trial designs using pathologic complete response, or pCR, as an endpoint in neoadjuvant breast cancer studies for patients with aggressive, early-stage breast cancer. Read More
Australia’s Therapeutic Goods Administration has set a September deadline for companies to adopt a common technical document format for over-the-counter drug submissions. Read More
The U.S. Food and Drug Administration has released a proposed rule allowing it to destroy certain drug imports that have been refused entry into the U.S. — the latest attempt to boost the integrity of the U.S. supply chain. Read More
The European Medicines Agency is urging drugmakers to implement and maintain security procedures for electronic safety-and-acknowledgement messages sent via the internet, and has issued guidance on the technical requirements around online data protection. Read More
The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More
U.S. lawmakers are asking the Office of the United States Trade Representative to put Canada back on its priority watch list after the country withdrew a number of patents for drugs sold by American manufacturers. Read More
Generic drugmakers in the U.S. and EU are calling on regulators to create uniform approval pathways for biosimilars and generic medicines, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is now accepting applications for its Early Access to Medicines Scheme, which allows drugs for life-threatening diseases to be approved on an interim basis so that patients can get them sooner. Read More
Drugmakers that are obtaining biotechnology-derived proteins in the EU should include effective evaluation and verification studies in their process validation documentation, the European Medicines Agency says. Read More