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FDA Amends Regs to Include Tobacco

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Federal Register Direct final rule: FDA amends it s regulations to include tobacco products where appropriate.

Comment Sought on National Stockpile Regulations

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Federal Register Notice: FDA seeks comments on information collection requirements on labeling requirements for products held by t...

Comments Sought on FDA Focus Group Info

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Federal Register Notice: FDA seeks comments on FDA focus groups used to gauge public opinion on FDA-regulated products.

Comments Sought on Radioactive Drug Regs Info

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Federal Register Notice: FDA seeks comments on the information collection in regulations on the use of radioactive drugs for basic...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Align Technology, Anchor Products Co., Energy Technology, and Gunnell.

Inspire Medical to Begin Pivotal Apnea Trial

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FDA gives Inspire Medical Systems approval to begin a pivotal clinical trial called STAR (Stimulation Therapy for Apnea Reduction)...

Review Process Strains FDA-Industry Relations

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PricewaterhouseCoopers says relations between industry and FDA over regulatory review processes are becoming strained.

FDA Grants 'Orphan' Status for Radiation Exposure Drug

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FDA grants Cleveland BioLabs an orphan drug designation for CBLB502, a drug under development for treating radiation exposure.

CDER Affirms Ranbaxy Generic Aricept Exclusivity

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CDER says that Ranbaxy is entitled to 180-day marketing exclusivity for generic Aricept.

Concerns Raised About ABSSSI Draft Guidance

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PhRMA raises concerns with two aspects of an FDA draft guidance on developing drugs to treat acute bacterial skin and skin structu...