Regulatory Roundup for Week of January 7, 2013 - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Regulatory Roundup for Week of January 7, 2013


FDA’s Orphan Drug Act celebrates its 30th year in 2013. Gayatri R. Rao, MD, JD, director for The Office of Orphan Products Development, provides highlights of the past 30 years of the Act.

A list of FDA’s 2012 new, revised, and withdrawn guidance documents can be found at fda.gov.

FDA released the following guidance documents in late December 2012 and early January 2013:

Guidance for Industry, Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, draft guidance, FDA, CDER, CBER, January 2013. This guidance provides the requirements for a valid electronic submission under section 745A(a) of the FD&C Act.

Guidance for Industry and Investigators, Safety Reporting Requirements for INDs and BA/BE Studies, FDA, CDER, CBER, December 2012. This guidance is intended to help sponsors and investigators comply with the requirements for investigational new drug (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies under 21 CFR 312.32, 312.64(b), and 320.31(d)(3).

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

Click here