Biotechnology/Biologics US-FDA

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FDA Issues Draft Guidance on Regulating Genetically Engineered Animals

Public comment invited on application of new animal drug provisions of the Federal Food Drug and Cosmetic Act

Date: 09/18/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01887.html

Beware of drug names that look, sound alike

Celebrex or Celexa? 1,500 common meds have caused mix-ups, study says

Date: 09/01/2008 , Publication: MSNBC , Author: LURAN NEERGAARD AP

http://www.msnbc.msn.com/id/26497545/

FDA Announces Improved Policies Regarding Transparency, Public Disclosure for Advisory Committees

The improvements include stricter limits on financial conflicts of interest for committee members, ...

Date: 08/05/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01871.html

Little monitoring for 'off-label' drug marketing

Report: FDA doesn't track drug makers peddling meds for unapproved use

Date: 07/27/2008 , Publication: MSNBC , Author: AP

http://www.msnbc.msn.com/id/25874072/

FDA Rule and Companion Guidance Make Early Stage Clinical Drug Development Safe and Efficient

Date: 07/19/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01863.html

FDA Revises Process for Responding to Drug Applications

The U.S. Food and Drug Administration today announced that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.

Date: 07/09/2008 , Publication: FDA News , Author: FDA

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01859.html

Possible lymphoma link to TNF-blockers sparks agency review

...including adalimumab (Humira, Abbott), etanercept (Enbrel, Amgen/Wyeth), infliximab (Remicade, Centocor), and certolizumab pegol (Cimzia, UCB Inc.)for data on all cases of cancer reported in children and young adults...

Date: 06/06/2008 , Publication: Drug Topics Daily News , Author: Heidi Belden, Pharm.D.

http://drugtopics.modernmedicine.com/drugtopics/Allergies/Possible-lymphoma-lin

F.D.A. Reviews Arthritis Drugs for Links to Cancer

...investigating whether four drugs used to treat rheumatoid arthritis and other immune system diseases might increase the risk of cancer in children.

Date: 06/05/2008 , Publication: NY TIMES , Author: ANDREW POLLACK

http://www.nytimes.com/2008/06/05/business/05drug.html?ref=health

F.D.A. to Expand Scrutiny of Risks From Drugs After They're Approved for Sale

The new system, called the Sentinel Initiative, will allow officials from the Food and Drug Administration for the first time to monitor almost immediately how drugs affect health...

Date: 05/23/2008 , Publication: NY TIMES , Author: GARDINER HARRIS

http://www.nytimes.com/2008/05/23/washington/23fda.html?ref=health

FDA to launch pilot on drug names and safety

FDA is holding a meeting, launching a pilot, and releasing a concept paper about drug names next month.

Date: 05/13/2008 , Publication: Drug Topics Daily News , Author: Judy Chi

http://drugtopics.modernmedicine.com/drugtopics/Government+And+Law/FDA-to-launc

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