Department of Health and Human Services February 15, 2019 – Federal Register Recent Federal Regulation Documents
Results 51 - 57 of 57
Advisory Council on Blood Stem Cell Transplantation
HHS is hereby giving notice that the Advisory Council on Blood Stem Cell Transplantation (ACBSCT) has been renewed. The effective date of the renewed charter is February 19, 2019.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
Established Conditions; Pilot Program
The Food and Drug Administration (FDA or Agency), Center for Drug Evaluation and Research (CDER) is announcing the opportunity for a limited number of applicants to participate in an Established Conditions Pilot Program, to propose explicit established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA), or as a prior approval supplement (PAS) to any of these. The concept of ECs was first described in the FDA draft guidance for industry entitled ``Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products'', issued May 2015 and has been further discussed in the International Council for Harmonisation (ICH) draft guidance for industry entitled ``Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation'', issued May 30, 2018. FDA is implementing this pilot program to gain experience receiving, assessing, and engaging with applicants regarding proposed ECs (i.e., explicit ECs).
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