and Cosmetic Act

Results: 5012



#Item
971Technology / Pharmaceuticals policy / Food law / Pharmaceutical industry / United States Public Health Service / Medical device / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Medicine / Food and Drug Administration / Health

Federal Register / Vol. 60, No[removed]Tuesday, July 18, [removed]Rules and Regulations products on the Commerce Control List is controlled according to the provisions in each Category. ‘‘Technology’’ ‘‘required

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972Implants / Restorative dentistry / Oral surgery / Dental implant / Medical device / Federal Food /  Drug /  and Cosmetic Act / Magnetic resonance imaging / Medicine / Medical technology / Prosthetics

FDA Questions For Panel Endosseous Dental Implants (Blade-form Class III) Meeting of the Dental Products Panel of the Medical Devices Advisory Committee Gaithersburg, MD July 18, 2013

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973Pharmaceutical sciences / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Medical device / Validation / Food and Drug Administration / Medicine / Health

Actions and Reports with a Due Date Specified by the Medical Device User Fee and Modernization Act of 2002 and the Medical Devices Technical Corrections Act Includes Actions Required by Regulations and Notices Issued to

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974Health / Pharmaceutical industry / Drug safety / Pharmaceuticals policy / Clinical research / New Drug Application / Federal Food /  Drug /  and Cosmetic Act / Investigational New Drug / Generally recognized as safe and effective / Food and Drug Administration / Medicine / Pharmaceutical sciences

CDER Office of Compliance Office of Drug Security, Integrity & Recalls Division of Import Operations & Recalls Imports Exports Compliance Branch FDA compliance focal point for imports & exports of CDER regulated drugs

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975Health / Federal Food /  Drug /  and Cosmetic Act / Abbreviated New Drug Application / New Drug Application / Food and Drug Administration / Medicine / Pharmaceutical sciences

The Form FDA356v Q: Is the Form FDA 356v required when I submit using the electronic eSubmitter tool? A: No. The Form FDA 356v is only required when submitting in paper. Q: What is Form FDA 356v? A: If data or informatio

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976Technology / Pharmaceuticals policy / Premarket approval / Pharmaceutical industry / Medical equipment / Medical device / Good manufacturing practice / Federal Food /  Drug /  and Cosmetic Act / Center for Devices and Radiological Health / Medicine / Food and Drug Administration / Health

Device Classification and Reclassification

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977Medical equipment / Membrane technology / Implants / Hemodialysis / Medical device / Port / Dialysis catheter / Federal Food /  Drug /  and Cosmetic Act / Food and Drug Administration / Medicine / Catheters / Renal dialysis

Microsoft Word - implanted blood access device panel questions[removed]FINAL.doc

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978Pharmaceutical sciences / Prescription Drug User Fee Act / Federal Food /  Drug /  and Cosmetic Act / New Drug Application / Center for Drug Evaluation and Research / FDA Fast Track Development Program / Food and Drug Administration / Medicine / Health

NDAs and BLAs: Communication to Applicants of Planned Review Timelines

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979Technology / Federal Food /  Drug /  and Cosmetic Act / Premarket approval / Medical device / Humanitarian Device Exemption / Investigational Device Exemption / Food and Drug Administration / Medicine / Health

510k Approval - National Donor Deferral Registry (NDDR)1.0, American Blood Resources Association

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980Pharmaceuticals policy / Antimicrobial / Microbiology / Medical device / Center for Devices and Radiological Health / Premarket approval / Federal Food /  Drug /  and Cosmetic Act / Antibiotic resistance / Disinfectant / Medicine / Health / Food and Drug Administration

Microsoft Word - ANTIMICROBIAL Guidance final[removed]accepted all changes.DOC

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