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Guidance on Unapproved OTC Sunscreen Product Enforcement

06/17/2011

Federal Register Notice: FDA is making available a draft guidance for industry, Enforcement Policy — OTC Sunscreen Drug Prod...

FDA Proposes to Limit Sunscreen SPF Value

06/17/2011

Federal Register Proposed rule: FDA is proposing to limit the maximum labeled SPF value for over-the-counter (OTC) sunscreen drug ...

OMB OKs Info on Radioactive Drug Research

06/17/2011

FDA Sets Unapproved Sunscreen Requirements

06/17/2011

Comments Sought on OTC Sunscreen SPF Requirements

06/17/2011

Federal Register Comment request: FDA is seeking public comment on SPF labeling and testing requirements for over-the-counter (OTC...

Data Sought on Unapproved OTC Sunscreens in Certain Dosage Forms

06/17/2011

Federal Register Advance notice of proposed rulemaking: FDA is asking sunscreen manufacturers and other interested parties to subm...

Panel to Discuss Seattle Genetics BLA for Hodgkin’s Lymphoma

06/17/2011

Federal Register Notice: FDA’s Oncologic Drugs Advisory Committee will meet 7/14, from 8 a.m. to 5 p.m. at the FDA White Oak...

Guidance on Clinical Trial Endpoints for Lung Cancer Drugs, Biologics

06/17/2011

Comments Extended on Generic Drug User Fee Program

06/08/2011

Federal Register Notice: FDA is extending the comment period for the 8/9/10 notice of public meeting, that requested comments to g...

Guidance on Citizen Petitions and Petitions for Stay of Action

06/08/2011