Department of Health and Human Services November 25, 2020 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services is issuing this Notice to withdraw FDA's Marketed Unapproved DrugsCompliance Policy Guide, Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs, and to request information from the public regarding drugs that may be grandfathered or generally recognized as safe and effective.

Findings of research misconduct have been made against Dr. David J. Panka (Respondent), former Harvard Medical School (HMS) Instructor of Medicine, and former HMS Associate Professor of Medicine at Beth Israel Deaconess Medical Center (BIDMC). Dr. Panka engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Cancer Institute (NCI), National Institutes of Health (NIH), grants P50 CA093683 and P50 CA101942. The administrative actions, including supervision for a period of three (3) years, were implemented beginning on November 9, 2020, and are detailed below.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA.'' This guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) to FDA an abbreviated new drug application (ANDA) for a complex product. Specifically, this guidance provides information on requesting and conducting product development meetings, presubmission meetings, and midreview cycle meetings with FDA. This guidance will assist applicants in generating and submitting a meeting request and the associated meeting package to FDA for complex products to be submitted under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and as contemplated in the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years (FYs) 2018-2022 (GDUFA II). This guidance finalizes the draft guidance of the same title issued on October 3, 2017.

Under an Executive Order that directs federal agencies to address the economic emergency created by the COVID-19 pandemic by rescinding, modifying, waiving, or providing exemptions from regulations and other requirements that may inhibit economic recovery, consistent with applicable law and with protection of the public health and safety, with national and homeland security, and with budgetary priorities and operational feasibility. The Order directs agencies to ``identify regulatory standards that may inhibit economic recovery'' and to take appropriate action such as rescission or suspension of regulations, including by use of good cause or emergency authorities where appropriate. Agencies have likewise been called on to assess the various temporary deregulatory actions they have taken to fight COVID- 19 and its impact on our economy to determine which temporary regulatory actions should be made permanent. The Order directs agencies to assist businesses and other entities in complying with the law through prompt issuance of pre-enforcement rulings and to formulate policies of enforcement discretion that recognize such entities' efforts to comply with the law.