HBW Insight 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 FDA Pill Size Guidance Helps Brands Stifle Competition

This article was originally published in The Tan Sheet

Executive Summary

FDA 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...



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denies ANDAs for one product because the generic tablet size is larger than the brand; the agency plans to release a draft guidance on generic equivalency to the reference listed drug in size, taste and smell.

Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs

GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.

Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says

Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

RS123242

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