FTC and DoJ issue guidance for businesses working together to tackle coronavirus pandemic; BIO is 'pleased' they intend to help facilitate critical partnerships.
As biopharma companies begin collaborating on development of treatments for COVID-19, the US Federal Trade Commission and Department of Justice offer assurance that they will get speedy answers to any antitrust questions.
The FTC and DOJ issued a joint statement on 24 March saying they would respond quickly to requests for...
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
