FDA Policy/General
Federal Register notice: FDA has canceled an 11/22 Oncologic Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplemental NDA for Zejula (niraparib) capsules. Panel members were scheduled to discuss the drug’s use for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal
FDA Policy/General
Federal Register notice: FDA is announcing a 12/7-8 virtual public meeting entitled “Drug Supply Chain Security Act Implementation and Readiness Efforts for 2023.” Topics to be discussed are stakeholder experiences with implementation and overall readiness regarding implementing enhanced drug distribution security requirements that will go into effect on
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Angel Medical Systems’ AngelMed Guardian System, a device indicated for use in patients who have had prior acute coronary syndrome events and who remain at high risk for recurrent events. The regulatory review period is
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Kyowa Kirin’s Nourianz (istradefylline), indicated as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing “off” episodes. The regulatory review period is 7,300 days, of which 2,792 days
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial.” The document provides recommendations to sponsors about studying multiple versions of a cellular or gene therapy product in an early phase clinical trial
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “M10 Bioanalytical Method Validation and Study Sample Analysis.” The International Council for Harmonization document describes recommendations for method validation for bioanalytical assays for nonclinical and clinical studies that generate data to support regulatory submissions, including the procedures and processes
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Postmarket Surveillance of Medical Devices — 21 CFR Part 822” (OMB Control Number 0910-0449). Agency regulations establish procedures that it uses to approve and disapprove postmarket surveillance plans. The regulation provides instructions to manufacturers, so they know
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Certification of Identity; Form FDA 3975” (OMB Control Number 0910-0832). The collection supports the form that is used by the agency to identify an individual requesting a particular record under the Freedom of Information Act (FOIA)
FDA Policy/General
FDA commissioner Robert Califf tested positive for Covid-19 over the weekend while traveling on official agency business. “He is up to date on vaccines against Covid-19 and is experiencing mild symptoms,” the agency said late Monday. Commissioner Califf has not recently been in close contact with President Biden
FDA Policy/General
A white paper called “What Needs to Change at the FDA” says the agency’s evidence standards have become distorted, which have led to decisions that often favor industry interests over those of the public, and an “anecdotal ideology among FDA senior management that patients are willing to accept more
FDA Policy/General
After 32 years at FDA, Center for Veterinary Medicine director Steven Solomon is retiring at the end of the year. He began his career at the agency as a veterinary medical officer in the Division of Surveillance and Compliance, according to an email from commissioner Robert Califf. He then moved
FDA Policy/General
Federal Register notice: FDA has issued an order permanently debarring Gregory Settino from providing services in any capacity to a person that has an approved or pending drug product application. The order was based on Settino’s conviction for stealing the injectable equine drug Adequan, which is administered to horses
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.” The document says that in many cases submission and approval of a comparability protocol will facilitate the subsequent implementation and reporting
FDA Policy/General
Federal Register notice: FDA is announcing an opportunity for public comment on a statement of work to assess communication between FDA and sponsors through product quality information requests during NDA/BLA reviews, and to identify best practices and areas of improvement. The independent assessment is part of FDA performance commitments
FDA Policy/General
Federal Register notice: FDA is seeking consumer organizations that are interested in participating in selecting voting and nonvoting consumer representatives to serve on its advisory committees or panels. Interested partied should notify FDA in writing. The agency is also requesting nominations for voting and nonvoting consumer representatives to serve on
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111” (OMB Control Number 0910-0606). To view the notice, click here.
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) is proposing research into how consumers and healthcare professionals interpret the proprietary names of drugs. OPDP says the results of the research will be useful to it in its role as one of several agency entities that evaluate proposed proprietary drug names.
FDA Policy/General
Federal Register notice: FDA has extended the comment period for a draft guidance entitled “Laser-Assisted In Situ Keratomileusis (LASIK) Lasers — Patient Labeling Recommendations.” Electronic and written comments on the draft guidance can now be submitted until 11/25. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing a voluntary Total Product Life Cycle (TPLC) Advisory Program (TAP) pilot that was agreed to between FDA and industry as part of the reauthorization of the Medical Device User Fee Amendments. TAP is intended to help spur more rapid product development by evaluating the
FDA Policy/General
Federal Register notice: FDA has announced the user fee rates for fiscal year 2023 for medical devices. The agency notes that due to the late date the user fee program was reauthorized, facility and program fees for FY 2023 should be paid within 30 days of this notice. To view
FDA Policy/General
Federal Register: FDA has announced that it has revoked an emergency use authorization issued to Laboratorio Clinico Toledo, Puerto Rico, for its Laboratorio Clinico Toledo SARS– CoV–2 Assay. The company told FDA that it is no longer using the test in its Covid-19 testing. To view the notice,
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Facility Readiness: Goal Date Decisions Under GDUFA.” The document tells applicants how FDA will use information about a facility’s readiness for inspection as certified on Form FDA 356h to set a goal date for an original ANDA. To