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FDA Changes Regs on Albuterol Inhalers

04/04/2005

Federal Register Final rule: FDA is amending its regulation on the use of ozone-depleting substances in self-pressurized container...

Guidance on Pharmacovigilance Planning

04/01/2005

Federal Register Notice: FDA is making available a guidance entitled E2E Pharmacovigilance Planning. The guidance was prepared und...

Info on Device Labeling Sent to OMB

04/01/2005

Federal Register Notice: FDA submitted a proposed collection of information entitled “Medical Device Labeling Regulations &#...

Three Risk Management Guidances Available

03/30/2005

Federal Register Notice: FDA is making available three guidances for industry entitled Premarketing Risk Assessment, Development a...

Info on OTC Drug Labeling Sent to OMB

03/30/2005

Federal Register Notice: FDA’s proposed collection of information, “Format and Content for Over-the-Counter (OTC) Drug...

Kemstro and Droxia Referred for Pediatric Studies

03/30/2005

Federal Register Notice: FDA is referring Kemstro (baclofen) and Droxia (hydroxyurea) to the Foundation for the National Institute...

Guidance on Lupus Drugs

03/30/2005

Federal Register Notice: FDA makes available a draft guidance entitled Systemic Lupus Erythematosus — Developing Drugs for T...

Chiron’s Pulminiq to Go Before FDA Panel

03/30/2005

Federal Register Notice: FDA’s Pulmonary-Allergy Drugs Advisory Committee will meet 6/6, from 8 a.m. to 5:30 p.m. at the CDE...

FDA OKs Schering-Plough sNADA

03/30/2005

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a supplemental NADA filed by Scher...

Blood Cell Separator into Class II

03/10/2005

Federal Register Proposed rule: FDA is proposing to reclassify from Class III to Class II (special controls) the automated blood c...