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Guidance on Determining if a Study Requires an IND

10/14/2010

Federal Register Notice: FDA is making available a draft guidance, Investigational New Drug Applications (INDs) — Determinin...

Guidance on INDs with Live Biotherapeutic Products

10/14/2010

Federal Register Notice: FDA is making available a draft document, Guidance for Industry: Early Clinical Trials with Live Biothera...

Modifications to Device Standards Published

10/04/2010

Federal Register Notice: FDA is making available, “Modifications to the List of Recognized Standards, Recognition List Numbe...

FDA Clarifies P&U sNADAs for Heifer Feed

09/30/2010

Federal Register Final rule: FDA is amending the animal drug regulations to more accurately reflect the recent approval (10/09) of...

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 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 ...

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...

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Federal Register Notice: FDA is making available a draft guidance for industry, Suicidality: Prospective Assessment of Occurrence ...