FDA Policy/General
Federal Register notice: CDER is announcing its Novel Excipient Review Pilot Program. The voluntary pilot would allow excipient manufacturers to gain FDA review of certain novel excipients prior to their use in drug formulations. It is intended to foster excipient development that may be useful in scenarios in which excipient
FDA Policy/General
Federal Register notice: FDA is correcting an 8/10 notice announcing a 9/17 Pediatric Advisory Committee meeting. It was published with the incorrect docket number and end time of the meeting. This document corrects those errors. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Reclassification Petitions for Medical Devices” (OMB Control Number 0910-0138). To change a device classification, FDA can initiate a reclassification, or an interested person can petition FDA to reclassify a device based on new information. The FDA
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Labeling Requirements for Prescription Drugs ” (OMB Control Number 0910-0572). The collection supports FDA regulations that set general requirements and specific content and format requirements. It is being revised to include the estimated “burden” associated with regulations
FDA Policy/General
Federal Register notice: FDA announces a 9/17 Vaccines and Related Biological Products Advisory Committee meeting to discuss a Pfizer-BioNTech supplemental BLA for their covid-19 vaccine Comirnaty and its use as a third dose or booster in individuals 16 years of age and older. To view the notice,
FDA Policy/General
Mammography QA Panel Renewed for 2 Years 9/3/2021 Federal Register notice: FDA has renewed its National Mammography Quality Assurance Advisory Committee for an additional two years beyond its charter expiration date. The new charter will be in effect until 7/7/2023. To view the notice, click here.
FDA Policy/General
DEVICES FDA has approved a Qiagen PMA supplement extending the indications for use of the company’s Therascreen EGFR companion diagnostic to guide the use of Boehringer Ingelheim’s targeted therapy Gilotrif (afatinib) for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with non-resistant epidermal growth
FDA Policy/General
Federal Register notice: FDA has renewed its National Mammography Quality Assurance Advisory Committee for an additional two years beyond its charter expiration date. The new charter will be in effect until 7/7/2023. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 10/28 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss the accelerated approval of an Oncopeptides NDA for Pepaxto (melphalan flufenamide) for injection for treating adult patients with relapsed or refractory multiple myeloma who have received at least four prior
FDA Policy/General
FDA’s authority to issues regulations without HHS authority has been restored. A 9/2 HHS Federal Register notice says such authority that is normally delegated to the agency level was rescinded 9/15/2020 during the previous administration. The notice notes that such delegation to FDA “shall be exercised
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Medical Device User Fee Cover Sheet, Form FDA 3601 and Device Facility User Fee Cover Sheet, Form FDA 3601a” (OMB Control Number 0910-0511). The revision adds Form FDA 3601a, which is designed to collect payments for
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Drug Supply Chain Security Act Implementation” (OMB Control Number 0910-0806). The collection supports FDA regulations requiring drug distributors to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in
FDA Policy/General
Former FDA associate chief counsel for litigation James Fraser has joined Greenberg Traurig’s Washington D.C. office. A firm statement says Fraser will work in its Litigation and Health Care and FDA practices as well as focusing on litigation matters in the Products Liability and Mass Torts and Pharmaceutical,
FDA Policy/General
Federal Register notice: FDA has announced an 11/4 Psychopharmacologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Levo Therapeutics NDA for carbetocin nasal spray, for the proposed treatment of hyperphagia, anxiety, and distress behaviors associated with Prader-Willi syndrome. To view the notice, click here.
FDA Policy/General
Attorneys Anne Walsh and JP Ellison (Hyman, Phelps & McNamara) say the Department of Justice (DoJ) “quietly” changed the role of guidance documents by reversing two Trump administration policies on such documents. Writing in their firm’s FDA Law Blog, Walsh and Ellison say the first policy, from 2017, prohibited
FDA Policy/General
Federal Register notice: FDA has revoked 15 Emergency Use Authorizations (EUAs) — 12 decontamination systems for personal protective equipment, one bioburden reduction system for personal protective equipment, and two umbrella EUAs for certain imported, non-NIOSH (National Institute of Occupational Safety and Health)-approved disposable respirators. The revocations for the decontamination
FDA Policy/General
Federal Register notice: FDA has announced that it has revoked the Emergency Use Authorization (EUA) issued to Curative Inc. for its Curative SARS-Cov-2 Assay based on the company’s request. The company told the agency that it has transitioned to other EUA tests to be used at its
FDA Policy/General
Federal Register notice: FDA has made available two draft device-specific guidance documents for the Safety and Performance Based Pathway — Denture Base Resins: Performance Criteria for Safety and Performance Based Pathway and Facet Screw Systems: Performance Criteria for Safety and Performance Based Pathway. To view the notice, click here.
FDA Policy/General
Breckenridge’s Solifenacin Succinate ANDA Withdrawn 8/27/2021 Federal Register notice: FDA has withdrawn the approval of a Breckenridge Pharmaceutical ANDA for solifenacin succinate tablets (5mg and 10mg) after the company requested such action. The company’s request is related to a 1/23/2020 field alert report that
FDA Policy/General
DEVICES FDA has cleared a Qiagen 510(k) for the ipsogen JAK2 RGQ PCR Kit for detecting mutations affecting the Janus Tyrosine Kinase 2 (JAK2) gene. This is the first FDA-authorized test intended to help physicians in evaluating patients for suspected Polycythemia Vera (PV), according to the agency. The
FDA Policy/General
Federal Register notice: FDA has withdrawn the approval of a Breckenridge Pharmaceutical ANDA for solifenacin succinate tablets (5mg and 10mg) after the company requested such action. The company’s request is related to a 1/23/2020 field alert report that indicated the tablets may convert to solifenacin tartrate during
FDA Policy/General
Federal Register notice: CDER has announced that 10/18 is the effective date that it will begin rejecting submissions that fail either Electronic Common Technical Document (eCTD) validation 1551 or 1553, which are high severity validation errors. The validation is related to certain types of promotional material-related submissions, including