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Guidance on Preclinical Cellular and Gene Therapy Info

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Federal Register Notice: FDA releases a draft guidance on preclinical assessment of investigational cellular and gene therapy prod...

Upton to Lead Energy and Commerce Again

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House Energy and Commerce Committee chair Fred Upton announces subcommittee chairs and vice chairs.

FDA Clears NeuroMetrix Pain Nerve Stimulator

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FDA clears a NeuroMetrix 510(k) for a disposable electrode that is used in conjunction with its SENSUS device, a transcutaneous el...

FDA Approves Cometriq for Thyroid Cancer

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FDA approves Exelixis Cometriq for treating metastatic thyroid cancer.

Hearing on Nicotine Replacement Therapies

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Federal Register Notice: FDA plans a public hearing 12/17 to discuss applicable approval mechanisms and additional indications for...

OMB OKs Info on Tobacco Product Registration

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Federal Register Notice: The Office of Management and Budget approves an FDA collection of information on registration and product...

FDA to Act Against Unapproved Anti-Cyanide Poisoning Products

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Federal Register Notice: FDA intends to take enforcement action against unnaproved injectable drugs for treating cyanide poisoning...

FDA Withdraws Smokeless Tobacco Product Guidance

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Federal Register Notice: FDA withdraws an outdated guidance, Enforcement Policy Concerning Rotational Warning Plans for Smokeless ...

Meeting on State/Federal Roles in Pharmacy Compounding

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Federal Register Notice: FDA plans a public meeting 12/19 on state and federal roles for pharmacy compounding.

Despite Patient Deaths, Rx Compounder Gets Slap on the Wrist

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A Texas drug compounding operation and its owner get probation in a 2007 deadly compounding episode that allegedly caused three de...