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Fda stories:
Pfizer's Geodon gets expanded FDA approval
Nov 20th, 2009 - Forbes
NEW YORK -- Pfizer Inc. said Friday the Food and Drug Administration approved Geodon as a part of a combination maintenance treatment for bipolar disorder in adults. The new approval covers use of Geodon as an adjunct to lithium or valproate.
Dendreon's potential prostate cancer treatment Provenge gets May 1 FDA review date
Nov 20th, 2009 - ChicagoTribune
SEATTLE (AP) - Biotechnology company Dendreon Corp. said Friday the Food and Drug Administration will make a regulatory decision on the potential prostate cancer vaccine Provenge by May 1. The drug is aimed at treating prostate cancer...
FDA Warns of Bacteria in Nasal Spray
Nov 20th, 2009 - MedPage Today
WASHINGTON -- Several lots of Vicks Sinex nasal spray have been recalled because of bacteria found in the solution during a quality control inspection, the FDA announced. Drug manufacturer Proctor and Gamble issued the voluntary recall...
UPDATE 1-Covidien says FDA extends review of opiod pain drug
Nov 20th, 2009 - Reuters
* FDA sets Feb. 22, 2010, as new action date * Says FDA needs more time to review additional data Nov 20 (Reuters) - Covidien Plc (COV.N) said U.S. healthregulators extended...
FDA advisory panel backs safety of Spiriva Handihaler
Nov 20th, 2009 - Dispatch
WASHINGTON -- Federal health experts yesterday brushed off lingering safety questions about apopular inhaler drug and suggested that it carry bolder benefit claims. The...
Fda videos from YouTube:
- FDA Approves Depressant...Made by Pfizer, Despondex is the first drug designed to treat the symptoms of excessive perkiness.
- Aspartame, Brain Cancer...The approval of the artificial sweetener aspartame (E951) was the most contested in FDA history. The approval was not based on any scientific grounds but was granted due to political and financial pressure ...
- Why FDA Drugs Kill People...Why FDA Drugs Kill People - Mind Control Report Why do side effects not get discovered during clinical trials? Why do drugs get approved by the FDA, kill people have to be withdrawn from the ...
- FDA's Dr. Stephen Sundlof...FDA's Dr. Stephen Sundlof Dos and Don'ts During the Peanut Salmonella Outbreak
Fda from WikiPedia:
The Center for Drug Evaluation and Research has different requirements for the three main types of drug products: new drugs, generic drugs and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different excipients or inactive ingredients, is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to "new molecular entities": drugs which are not based on existing medications.
New drugs receive extensive scrutiny before FDA approval in a process called a New Drug Application or NDA. New drugs are available only by prescription by default. A change to Over the Counter (OTC) status is a separate process and the drug must be approved through an NDA first.
A drug that is approved is said to be "safe and effective when used as directed."
Read more on WikiPedia
