Generic Drug Market Has Gaps, FDA Tells Firms In Solicitation For ANDAs
Executive Summary
US agency unveils plans to speed reviews of generic applications in areas with limited competition and offers a list of potential targets, but threat to brands may be limited.
You may also be interested in...
FDA's Advisory Cmte. Meeting On Bladder Pain Syndrome May Signal Policy Changes
The Bone, Reproductive and Urologic Drugs Advisory Committee will consider endpoints, clinical trial designs and other issues related to development in the disease.
Generic Industry Gets 267 Reasons From FDA To Pursue ANDA Development
US agency’s list of off-patent, off-exclusivity drugs that lack generic versions is aimed at improving transparency and encouraging competition, but almost half the 267 listed products involve complex issues that would require further decision-making by FDA ahead of ANDA submission.
FDA Drug Pricing Policy Offers Short-Term PR Gain, More Long-Term Actual Benefit
Prioritizing ANDAs entering markets with fewer than three approved generics not expected to become a major advantage until first-cycle clearances increase.