Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Generic Firms Fear 'New Lifecycle Management Tool' From FDA Pill Size Guidance

This article was originally published in The Pink Sheet Daily

Executive Summary

Final guidance excludes attachment on capsules but otherwise is virtually identical to draft; GPhA had argued for flexibility in product design to avoid brand patents.

You may also be interested in...



Drug GMP and CMC Updates In Brief: Guidance Advances on Several Fronts

The US FDA revised two drug good manufacturing practice inspection programs in its compliance manual to reflect certain ICH guidance documents, efforts to control nitrosamine impurities and the use of inspection alternatives for evaluating facilities. Plus more recent developments in GMP and CMC compliance.

FDA Rejects Generic Tablets Larger Than Brand Citing Safety And Efficacy Concerns

FDA denies ANDAs for one product because the generic tablet size is larger than the brand; the agency plans to release a draft guidance on generic equivalency to the reference listed drug in size, taste and smell.

FDA Urged To Collaborate With USPTO On Orange Book Listings, Eliminate Patent Use Codes

Stakeholders suggest a variety of USPTO and FDA actions that could help ensure patents do not improperly delay generic and biosimilar competition.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS078615

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel