FDA Policy/General
Johns Hopkins University researchers say that higher direct-to-consumer (DTC) ad spending is associated with drugs that have a lower added benefit and higher total drug sales. Writing in JAMA, the researchers say further research is needed to understand the implications of their findings. In this study of 150
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “FDA Administrative Practices and Procedures; Formal Hearings.” The collection supports FDA regulations associated with the Administrative Procedures Act that cover formal evidentiary, public, and regulatory hearings. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined that 31 drug products were not withdrawn from sale due to safety or effectiveness reasons. The determinations permit the agency to approve ANDAs that reference the products as long as they meet relevant legal and regulatory requirements. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 3/28-29 public workshop entitled “Understanding Priorities for the Development of Digital Health Technologies To Support Clinical Trials for Drug Development and Review.” It is being convened by the Duke-Robert J. Margolis, MD Center for Health Policy under a cooperative agreement
FDA Policy/General
Federal Register notice: FDA has announced a 5/11 public workshop entitled “FY 2023 Generic Drug Science and Research Initiatives Workshop,” which will provide an overview and the status of science and research initiatives for generic drugs. The workshop will also provide an opportunity for public input on the research
FDA Policy/General
Federal Register notice: FDA is making available an annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” The report is mandated by the FD&C Act to provide the status of postmarketing requirements and postmarketing commitments that are required of
FDA Policy/General
Federal Register notice: FDA has issued an order permanently debarring Sami Anwar from providing services related to an approved or pending drug product application. The debarment is related to his recent convictions as the owner and operator of Mid-Columbia Research LLC and Zain Research LLC, contract research organizations that
FDA Policy/General
The Federal Trade Commission (FTC) says it has taken its first enforcement action under its Health Breach Notification Rule against the telehealth and prescription drug discount provider GoodRx court for failing to notify consumers and others of its unauthorized disclosure of consumers’ personal health information to Facebook, Google, and other
FDA Policy/General
Federal Register notice: FDA is announcing a 2/28 to 3/1 Vaccines and Related Biological Products Advisory Committee meeting to discuss two BLAs for respiratory syncytial virus (RSV) vaccines. On 2/28, panel members will review Pfizer’s vaccine Abrysvo for active immunization for preventing acute respiratory disease and
FDA Policy/General
Federal Register notice: FDA is announcing a 4/4-5 advisory committee meeting of the Science Advisory Board to the National Center for Toxicological Research (NCTR). On 4/4, panel members will hear an NCTR update on scientific initiatives and accomplishments during the past year. Additionally, officials from CBER, CDER,
FDA Policy/General
The Biden Administration has announced that it will end the current Covid-19 public health emergency (PHE) declaration and national emergency declaration, which were declared in 2020, on 5/11. FDA says a future Federal Register notice will be published on how the decision to end the PHE will affect
FDA Policy/General
FDA commissioner Robert Califf announced 1/31 a new “transformative vision” for the agency’s human foods program and the Office of Regulatory Affairs that addresses recommendations and findings from a 12/2022 external evaluation by the Reagan-Udall Foundation that the agency requested. Califf says the new proposed structures
FDA Policy/General
Federal Register notice: FDA is announcing the issuance of two Emergency Use Authorizations for diagnostic devices in response to the ongoing Monkeypox outbreak. One EUA was granted to Becton Dickinson for its Viasure Monkeypox virus Real Time PCR Reagents for the BD MAX System, and the other to DiaCarta, Inc.
FDA Policy/General
Federal Register notice: FDA is classifying software for optical camera-based measurements of pulse rate, heart rate, breathing rate, and/or respiratory rate into Class 2 (special controls). Such devices use software algorithms to analyze video signals and estimate pulse rate, heart rate, breathing rate, and/or respiratory rate, and
FDA Policy/General
CDER and CBER say that beginning 2/13 they will restart limited in-person, face-to-face industry meetings. It was just a matter of time for in-person industry meetings to restart after FDA commissioner Robert Califf announced late last year that FDA staff this year would be transitioning
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Premarket Approval of Medical Devices.” The collection is being revised to include the burden associated with recommendations related to the guidance entitled “Providing Information about Pediatric Uses of Medical Devices.” It is also being revised related to
FDA Policy/General
Federal Register notice: FDA is announcing a 3/20 joint meeting of its Nonprescription Drugs and Anesthetic and Analgesic Drug Products advisory committees. Panel members are scheduled to discuss a Harm Reduction Therapeutics NDA for naloxone hydrochloride nasal spray, 3 mg/0.1 mL, for proposed nonprescription use as an
FDA Policy/General
Rep. Anna G. Eshoo (D-CA) has been tapped as the ranking Democrat on the House Energy and Commerce Committee’s Health Subcommittee, which has primary oversight of FDA and other health agencies. During last Congress’ Democratic control, Eshoo served as chairwoman of the subcommittee. Now, with Republicans in control
FDA Policy/General
Federal Register notice: FDA’s Office of Operations (OO), Office of Enterprise Management Services (OEMS) has modified its organizational structure, which was approved 9/26/2022 by HHS. The reorganization realigned the agency’s History Office function from the Office of the Commissioner, Office of External Affairs to OO, OEMS.
FDA Policy/General
A section of the Food and Drug Omnibus Reform Act (FDORA), which was passed by Congress at the end of 2022, requires sponsors of most drug and medical device clinical studies to submit a diversity action plan when they submit key trial documents to the agency. The requirement will apply
FDA Policy/General
Federal Register notice: FDA has announced a 3/9 Oncologic Drugs Advisory Committee meeting to discuss a supplemental BLA for Polivy (polatuzumab vedotin-piiq) for injection. The submission proposes an indication for combination use with a rituximab product, cyclophosphamide, doxorubicin, and prednisone for treating adult patients with previously untreated diffuse
FDA Policy/General
Federal Register notice: FDA has issued a three-year debarment order against Poornanand Palaparty for providing services in any capacity to a person that has an approved or pending drug product application. FDA based the order on a finding that Dr. Palaparty, an oncologist, was convicted of a misdemeanor after