ANDA User Fee Negotiations: A Big-Firm Coalition Tackles The Big Backlog
FDA has long negotiated its brand user fee program with two distinct but closely aligned industry groups: the Pharmaceutical Research and Manufacturers of America and the Biotechnology Industry Organization. Now the agency will be using those same discussion techniques as it develops the generic drug user fee program.
More from Archive
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
More from Pink Sheet
The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.
The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.
The Medicines Control Authority of Zimbabwe has begun phasing in mandatory package labeling requirements based on GS1 identification standards. It aims to improve the traceability of medicines throughout the entire supply chain.