FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin. The document is intended to help potential applicants in determining when an application for a synthetic peptide drug product that refers to
Devices
FDA has published a guidance, Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, with its recommendations on testing to assess the safety and compatibility of medical devices in the magnetic resonance environment and the recommended format for magnetic resonance imaging safety information in medical device
Devices
FDA has published a guidance, Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages, extending to 9/24/23 the enforcement discretion date by which the agency does not intend to object to the use of legacy FDA identification
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus. The document provides recommendations for feasibility and early feasibility clinical studies for certain medical devices intended
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation — Non-Clinical Testing and Clinical Considerations. The agency defines implanted brain-computer interface devices as neuroprostheses that interface with the central or peripheral nervous system to restore
FDA Policy/General
Federal Register notice: FDA has made available a draft information sheet guidance for sponsors, clinical investigators, and institutional review boards entitled Frequently Asked Questions — Statement of Investigator (Form FDA 1572) (Revision 1). The document explains FDA’s current thinking on waivers of the signature requirement for Form FDA 1572. To
Drugs
FDA has extended to 10/17 the PDUFA target action date for Omeros’ BLA for narsoplimab to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy. The company says that as part of the BLA priority review, it submitted a response to an FDA information request that the agency classified as
FDA Policy/General
The Critical Path Institute (C-Path) has named former FDA commissioner Robert Califf to its board of directors. Califf was commissioner 2016-2017. A C-Path announcement says he currently is head of clinical policy and strategy for Google parent company Alphabet’s Verily Life Sciences and Google Health units.
FDA Policy/General
Federal Register notice: FDA has announced a 6/18 public meeting entitled “FDA Public Meeting on Financial Efficiency of Human Drug User Fee Programs.” The meeting will discuss financial transparency and efficiency of the Prescription Drug User Fee Act, the Biosimilar User Fee Act, and Generic Drug User Fee Amendments.
Devices
FDA says antibody tests should not be used at this time to determine immunity or protection against Covid-19, especially after a person has received a Covid-19 vaccination. A just-posted safety communication says: * The authorized Covid-19 vaccines induce antibodies to specific viral protein targets; post-vaccination antibody
Devices
FDA has published an updated final guidance, Peripheral Vascular Atherectomy Devices—Premarket Notification [510(k)] Submissions, with recommendations for 510(k) submissions for these devices. The document says the recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of peripheral vascular atherectomy submissions. In
Devices
FDA has published a guidance, Implanted Brain-Computer Interface (BCI) Devices for Patients with Paralysis or Amputation—Non-clinical Testing and Clinical Considerations, with recommendations for Q-submission and IDEs for implanted brain-computer interface (BCI) devices for patients with paralysis or amputation. The document says that because CDRH believes
Drugs
FDA has published a guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin, to assist potential applicants in determining when an application for a synthetic peptide that refers to a previously approved peptide drug product of rDNA origin should be submitted
Devices
FDA has published a draft guidance, Feasibility and Early Feasibility Clinical Studies for Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus, with study recommendations for these devices. The document says that while several legally marketed medical devices help patients manage Type 2
Drugs
Sens. Ron Wyden (D-OR), Rand Paul (R-KY), and Jeff Merkley (D-OR) have introduced legislation to ensure hemp-derived CBD (cannabidiol) products are regulated by FDA like other legal products used in dietary supplements, foods, and beverages. A joint statement (contains links to the bill text and bill
FDA Policy/General
FDA’s recently announced FDA Inspectional Affairs Council (FIAC), which will help plan and coordinate inspectional activities, is also intended to optimize the agency’s inspection program on an enterprise level, according to FDA associate commissioner for regulatory affairs Judy McMeekin. Delivering a keynote presentation at the Food and Drug
FDA Policy/General
FDA’s Office of Medical Policy clinical methodologies group has received a $9.2 million HHS grant to fund expansion of the CURE ID platform to allow automated data collection from electronic health records worldwide and clinical disease registries for Covid-19 and other difficult-to-treat infectious diseases. An
Drugs
Federal Register notice: FDA has made available a draft guidance entitled Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention. The document provides recommendations for trial population, trial design, efficacy considerations, and clinical outcome assessments. It was developed to detail a recent change in agency recommendations on the necessary evidence
Biologics
Iovance Biotherapeutics says FDA regulatory feedback on potency assays for lifileucel that were submitted to the agency will delay a planned BLA for the therapy. “Following FDA feedback, Iovance will continue its ongoing work developing and validating its potency assays and plans to submit additional assay data and to meet
Drugs
International business management consultancy Sedgwick says that while product recalls, including drugs and medical devices, have dropped during the pandemic, there is likely to be a surge in recalls as businesses return to more normal operating conditions. In a statement, Sedgwick says that in the first quarter of 2021, medical
Devices
The Pew Trusts says the Covid-19 pandemic has demonstrated the value in FDA reviewing laboratory-developed tests (LDTs) and says Congress should adopt reform legislation that would maintain the agency’s central role in overseeing diagnostic tests. An online paper says the agency’s regulatory authority over tests remains
FDA Policy/General
Federal Register notice: FDA is publishing a list of five information collections that have been approved by the Office of Management and Budget. They are: * Empirical Study of Promotional Implications of Proprietary Prescription Drug Names (0910-0896) * Adverse Experience Reporting for Licensed Biological Products; and General Records (0910-0308) * Export