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 The concept of ECs was first described in the FDA draft guidance for industry entitled ``Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products'', issued May 2015 and has been further discussed in the International Council for Harmonisation (ICH) draft guidance for industry entitled ``Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management; International Council for Harmonisation'',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).
Center for Drug Evaluation and Research's Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``CDER's Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality.'' This guidance describes a proposed program at FDA's Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of informally recognized voluntary consensus standards related to pharmaceutical quality. This program, once established, will facilitate submissions by external stakeholders and CDER staff proposing voluntary consensus standards related to pharmaceutical quality for informal recognition. CDER believes that this informal program, which is different than the formal recognition standards program in FDA's Center for Devices and Radiological Health, will help promote innovation in pharmaceutical development and manufacturing and streamline the compilation and assessment of marketing applications for products regulated by CDER. CDER is issuing this draft guidance to obtain public comments on the proposed program.
Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children
The Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has scheduled a public meeting. Information about the ACHDNC and the agenda for this meeting can be found on the ACHDNC website at https://www.hrsa.gov/advisory-committees/heritable- disorders/index.html.
Meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry
The Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD) has scheduled public meetings for the 2019 calendar year (CY). Information about ACTPCMD, agendas, and materials for these meetings can be found on the ACTPCMD website at https:// www.hrsa.gov/advisory-committees/primarycare-dentist/index.ht ml.
Meeting of the Council on Graduate Medical Education
The Council on Graduate Medical Education (COGME) has scheduled a public meeting. Information about COGME and the agenda for this meeting can be found on the COGME website at https://www.hrsa.gov/ advisory-committees/graduate-medical-edu/index.html.