HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

FDA Generics Office To Revise BCS Waiver Guidance Under Science Director

This article was originally published in The Tan Sheet

Executive Summary

FDA's Office of Generic Drugs is planning to revise the final guidance on biopharmaceutics classification system-based biowaivers under the leadership of Director for Science Lawrence Yu, PhD

You may also be interested in...



People In Brief

CHPA elections: Bayer Consumer Care North America Senior VP & Region Head Timothy Hayes named chairman-elect during association's annual conference in Aventura, Fla. March 13-15. He will succeed current chairman and Blistex President & COO Richard Green in 2004. Hayes was elected to CHPA's board in 2000; he joined its executive committee and chaired its finance committee the same year. Members elected to the trade group's board for the first time include Leiner Health Products President Gale Bensussen, Pfizer Consumer Healthcare North America President Gordon Knapp, P&G Global Personal Health Care VP Mary Lynn Ferguson-McHugh, Shaklee Senior VP & General Counsel Marjorie Fine...

Bioequivalence For Modified-Release Drugs Will Need Non-Replicate Studies

FDA's revised bioavailability/bioequivalence guidance recommends non-replicate study designs for modified-release dosage forms

ODE V Permanent Director Bull Brings Women’s Health, Analgesics Expertise

Jonca Bull, MD, will tackle Rx-to-OTC switch issues head-on in her first week as permanent director of FDA's Office of Drug Evaluation V

Related Content

Topics

UsernamePublicRestriction

Register

RS130451

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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