Regulatory Roundup: FDA Holds Biosimilars Public Hearing - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Regulatory Roundup: FDA Holds Biosimilars Public Hearing

ePT--the Electronic Newsletter of Pharmaceutical Technology

This week, the US Food and Drug Administration held a two-day public hearing to gain public input on how to implement and regulate the follow-on biologics pathway that was cleared via President Obama’s Biologics Price Competition and Innovation Act of 2009, which falls under the 2010 approved healthcare reform legislation. Members from the agency’s biologics and drug evaluation and research centers (the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research), as well as the Office of Compliance, were on the panel. Representatives from the major industry trade associations, the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), and the Generic Pharmaceutical Association (GPhA), gave presentations, as did other members of industry and healthcare. The transcript of the hearing will be available here. See the related PharmTech Talk blog post, Biosimilars Hearing Begins Today.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
14%
Provide treatment for patients globally.
7%
All of the above.
47%
No government involvement in patient treatment or drug development.
9%
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
New Congress to Tackle Health Reform, Biomedical Innovation, Tax Policy
Combination Products Challenge Biopharma Manufacturers
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here