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FDA Sends Info to OMB on ID Testing of Dietary Ingredients

09/30/2010

Federal Register Notice: FDA’s proposed collection of information, “Petition to Request an Exemption From 100 Percent ...

Panels to Discuss I.V. Anti-Seizure Drugs

09/16/2010

Federal Register Notice: FDA’s Peripheral and Central Nervous System Drugs Advisory Committee and the Drug Safety and Risk M...

Tobacco Panel to Discuss Menthol Cigarettes Impact

09/16/2010

Federal Register Notice: FDA’s Tobacco Products Scientific Advisory Committee will meet 10/7, from 8 a.m. until 5 p.m. and 1...

Review Period Set for SyntheMed’s Repel-CV

09/09/2010

Federal Register Notice: FDA has determined the regulatory review period for SyntheMed, Inc.’s Repel-CV is 4,023 days for ex...

Review Period Set for Ixiaro Vaccine

09/09/2010

Federal Register Notice: FDA has determined the regulatory review period for Chiel Jedang Corp. and Walter Reed Army Institute of ...

Guidance on Suicidality Assessment in Clinical Trials

09/09/2010

Federal Register Notice: FDA is making available a draft guidance for industry, Suicidality: Prospective Assessment of Occurrence ...

FDA OKs Novartis sNADA for Swine Diseases

09/08/2010

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Novartis Animal Health supplemen...

Special Controls Guidance on Coronary Angioplasty Catheters

09/08/2010

Federal Register Notice: FDA is making available a guidance, Class II Special Controls Guidance Document for Certain Percutaneous ...

FDA Reclassifies Coronary Angioplasty Catheters

09/08/2010

Federal Register Final rule: FDA is reclassifying the device type, standard percutaneous transluminal coronary angioplasty (PTCA) ...

FDA Codifies Ophthalmic Solution for Dogs

09/08/2010

Federal Register Final rule: FDA is amending the animal drug regulations to codify the conditions of use of an approved NADA for g...