Generics US-FDA

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From the Editor: Post-regulatory

The Acomplia story isn't ending. It's just beginning.

Date: 07/03/2007 , Publication: Pharmaceutical Executive , Author: Patrick Clinton

http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=442273

VIDEO Exclusive Video Interview with CDER Director, Steven Galson, MD VIDEO

Exclusive Video Interview with CDER Director, Steven Galson, MD on Drug Risks, Regulation and Research

Date: 06/24/2007 , Publication: Pharmaceutical Executive , Author: Jill Wechsler

http://www.advanstar.com/test/pharmascience/pha-sci_supp-promos/phasci_reg_guid

FDA's Winckler talks about the agency's goals

In September 2006, Susan Winckler, R.Ph., J.D., joined the Food & Drug Administration as acting chief of staff.

Date: 06/21/2007 , Publication: Drug Topics , Author: Sandra Levy

http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=426519

Generic Drugs: Trends in FDA Approval

All approved drugs, both innovator and generic, are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

Date: 06/01/2007 , Publication: US Pharmacist , Author: Somnath Pal, BS (Pharm), MS, MBA, PhD

http://www.uspharmacist.com/index.asp?show=article&page=8_2050.htm

Q&A with GPhA President and CEO Kathleen Jaeger

Generic Pharmaceutical Association: www.gphaonline.org

Date: 06/01/2007 , Publication: US Pharmacist , Author: Editor

http://www.uspharmacist.com/index.asp?show=article&page=8_2054.htm

Generic Industry Outlook

Dynamic Changes Require Informed Decision Making

Date: 06/01/2007 , Publication: US Pharmacist , Author: Editor

http://www.uspharmacist.com/index.asp?show=article&page=8_2048.htm

FDA acts against unapproved cough, cold meds

Agency sets deadlines for manufacturers to stop making, shipping drugs

Date: 05/25/2007 , Publication: MSNBC , Author: Associated Press

http://www.msnbc.msn.com/id/18868410/

Latebreakers: Bill to give FDA more powers advances in Congress

...which gives the FDA more powers to require manufacturers to conduct postmarketing studieis to improve patient safety.

Date: 05/21/2007 , Publication: Drug Topics , Author: Drug Topics

http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=426775

New Critical Path Report Highlights Research Needed to Foster Generic Drug Development

The report is part of FDA's Critical Path Initiative, established in 2004 to discern what challenges exist in moving a promising drug, biologic or device along the critical path from discovery, or proof of concept, to a marketable product

Date: 05/02/2007 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01626.html

FDA Warns Consumers about Counterfeit Drugs from Multiple Internet Sellers

The Food and Drug Administration (FDA) is cautioning U.S. consumers about dangers associated with buying prescription drugs over the Internet.

Date: 05/01/2007 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01623.html

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Search returned 179 items.