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Federal Register Notice: FDA is making available a draft guidance for industry, Enforcement Policy — OTC Sunscreen Drug Prod...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