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When it comes to disclosing clinical trial data in the biotechnology arena, in particular for public biotech companies, timing is everything. Disclosures are not just about when to reveal the information, but also what is...more
In January 2024, the Office of Compliance at the FDA’s Center for Drug Evaluation Research (CDER) released its Annual Report for FY2023. The Annual Report contains several useful pieces of information for drug companies and...more
Medical Devices Directorate Performance Annual Report - In September 2023, Health Canada published the Medical Devices Directorate Performance Annual Report for April 1, 2022, through March 31, 2023. The report provides...more
Since our last update, the Senate confirmed Dr. Robert Califf as commissioner of the U.S. Food and Drug Administration. The FDA resumed domestic and foreign inspections. The agency also published a proposed rule to update...more
On 18 December 2020 the Interagency Food Safety Analytics Collaboration (IFSAC) announced the release of its 2018 annual report on the sources of foodborne illness involving the pathogens Salmonella, Escherichia coli (E....more
On July 23, the U.S. Food and Drug Administration (FDA) announced a new proposed rule that would require sponsors and manufacturers who provide an ‘‘eligible investigational drug’’ under the Right to Try Act to submit an...more
The Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: A Progress & Outlook Report” (Report) that monitors current successes and challenges in bringing personalized therapies to market....more
FDA Amends Waivers to Sanitary Transportation Rule - On April 6, 2017, the Food and Drug Administration ("FDA") notified industry regarding the amendment of waivers available under the Sanitary Transportation of Human...more