+ Site Statistics
+ Search Articles
+ PDF Full Text Service
How our service works
Request PDF Full Text
+ Follow Us
Follow on Facebook
Follow on Twitter
Follow on LinkedIn
+ Subscribe to Site Feeds
Most Shared
PDF Full Text
+ Translate
+ Recently Requested

Food and Drug Administration Modernization Act of 1997; list of documents issued by the Food and Drug Administration that apply to medical devices regulated by the Center for Biologics Evaluation and Research. Food and Drug Administration, HHS. Notice



Food and Drug Administration Modernization Act of 1997; list of documents issued by the Food and Drug Administration that apply to medical devices regulated by the Center for Biologics Evaluation and Research. Food and Drug Administration, HHS. Notice



Federal Register 64(79): 20312-3



The Food and Drug Administration (FDA) is publishing a list of documents issued in response to the Food and Drug Administration Modernization Act of 1997 (FDAMA), and clarifying their applicability to medical devices regulated by the Center for Biologics Evaluation and Research (CBER). This notice is intended to inform the public of the availability of these documents, clarify their scope of applicability, and to provide instructions on ways to access them.

Please choose payment method:






(PDF emailed within 1 workday: $29.90)

Accession: 046111349

Download citation: RISBibTeXText

PMID: 10558481


Related references

Memorandum of understanding between the Food and Drug Administration and the U.S. Army Medical Research and Material Command. Food and Drug Administration, HHS. Notice. Federal Register 64(95): 26988-26991, 1999

Medical devices; implementation of third party review under the Food and Drug Administration Modernization Act of 1997; emergency processing request under OMB review--FDA. Notice. Federal Register 63(99): 28388-28391, 1998

Parenteral Drug Association statement to the Food and Drug Administration Center for Biologics Evaluation and Research on the General Biologics Licensing Regulations January 26, 1995. Pda Journal of Pharmaceutical Science and Technology 49(3): 101-102, 1995

Anti-infective agents, biologics, and vaccines approved by the U.S. Food and Drug Administration's Center for Drug Evaluation and Research in 1993. Antimicrobial Agents and ChemoTherapy 38(4): 908-908, 1994

International Conference on Harmonisation; Electronic Transmission of Postmarket Individual Case Safety Reports for Drugs and Biologics, Excluding Vaccines; Availability of Food and Drug Administration Regional Implementation Specifications for ICH E2B(R3) Reporting to the Food and Drug Administration Adverse Event Reporting System. Notice of Availability. Federal Register 81(121): 40890-1, 2016

Agreed minutes; meeting between the Food and Drug Administration and the Health Authorities of Switzerland. Food and Drug Administration, HHS. Notice. Federal Register 64(107): 30038-30040, 1999

Advancing Public Health Using Regulatory Science to Enhance Development and Regulation of Medical Products: Food and Drug Administration Research at the Center for Biologics Evaluation and Research. Frontiers in Medicine 4: 71, 2017

A survey of currently active late-phase oncology studies for cellular, gene therapy and antigenic products regulated by the US Food & Drug Administration, Center for Biologics Evaluation and Research (CBER). Journal of Clinical Oncology 23(16_Suppl): 6063-6063, 2016

Jesse Goodman Named Director of Food and Drug Administration's Center for Biologics Evaluation and Research. Journal of Investigative Medicine 51(4): 178-178, 2003

Food and Drug Administration Modernization Act of 1997: medical device provisions. Food and Drug Law Journal 53(2): 267-295, 1998

Going 90 in a 55 M.P.H. speed zone: reprocessing of used single-use medical devices and the Food and Drug Administration's non-enforcement of the Food, Drug, and Cosmetic Act. Food and Drug Law Journal 56(1): 57-76, 2001

Public notice from the Food & Drug Administration's Center for Devices and Radiological Health. Ostomy/Wound Management 43(9): 84-84, 1997

Report of the Food and Drug Administration Subcommittee on Xenotransplantation: meeting of 13 January 2000, Center for Biologics Evaluation and Research. Xenotransplantation 7(2): 75-79, 2000

Report of the Food and Drug Administration Subcommittee on Xenotransplantation: meeting of 3 and 4 June, 1999, Center for Biologics Evaluation and Research. Xenotransplantation 6(4): 232-237, 1999

Food and Drug Administration; statement of organization, functions, and delegations of authority: Center for Biologics Evaluation and Research (CBER)--HHS. Federal Register 57(222): 54241-3, 1992