FDA Commissioner responds to GAO report on handling of complex generics

17 January 2018
drugs_pills_tablets_big

FDA Commissioner Scott Gottlieb has responded to a US Government report which criticised the unpredictability of changes the agency makes to guidance on complex generics.

This type of product is often based on a complex formulation or complex active ingredient which may make it more difficult for generics manufacturers to demonstrate equivalence with the reference product, compared with conventional generics.

The report stated that the FDA “issues new guidance documents and revises existing ones unexpectedly, which can create setbacks for generic drug companies.”

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Generics