FDA Policy/General
Federal Register notice: FDA is seeking comments on a new proposed information collection entitled “Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act.” Under the Act, FDA is required to enter into a contract with a consulting firm with expertise to conduct a technology and software assessment that
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products.” The document provides recommendations to nonprescription drug product applicants on documenting minor labeling changes in the next annual report. It also provides examples of minor labeling changes
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act.” The document identifies the information FDA generally considers to be necessary for cyber devices to support cybersecurity obligations under new amendments to the Federal
FDA Policy/General
Federal Register notice: FDA is announcing the renewal of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 1/22/2026. To view the notice, click here.
FDA Policy/General
The Center for Veterinary Medicine (CVM) says promotional communications for Boehringer Ingelheim Animal Health USA’s Senvelgo (velagliflozin oral solution) make false or misleading claims and representations about the drug’s safety and effectiveness. A 3/1 Warning Letter says the violations are especially concerning from a public health perspective
FDA Policy/General
An FDA-funded 9/14/2023 virtual public workshop on “The Future of Prescription Drug Promotion and Digital Marketing” convened by the Duke-Margolis Institute for Health Policy identified three cross-cutting themes as described in the institute’s meeting report: * the pace at which new marketing venues, technologies, and
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Early Alzheimer’s Disease: Developing Drugs for Treatment.” The document addresses drug clinical development for treating stages of sporadic Alzheimer’s disease that occur before the onset of overt dementia. It discusses the use of biomarkers reflecting underlying AD
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “FDA Adverse Experience Reporting for Licensed Biological Products; and General Records — 21 CFR Part 600.” The collection supports statutory and regulatory authorities that govern adverse experience reporting. To view the notice, click here.
FDA Policy/General
Federal Register proposed rule: FDA is proposing to revise the requirements for the content and format of labeling for approved or conditionally approved new animal drugs to provide a more comprehensive set of requirements in one location in the Code of the Federal Register. Under the revision, certain requirements would
FDA Policy/General
President Biden is seeking a $500 million boost in FDA’s spending in fiscal year 2025, which is 7.4% more than the current $6.7 billion spending level in FY 2024, according to just-released budget documents from the White House. The FY 2025 budget proposal says the president
FDA Policy/General
Federal Register notice: FDA is correcting a 2/22 notice announcing the availability of a final guidance entitled ‘‘Assessing Covid–19–Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for Covid–19 Prevention or Treatment.” The document was published with an incorrect
FDA Policy/General
Federal Register notice: FDA is announcing 5/9 Blood Products Advisory Committee meeting that will consider strategies to reduce the risk of transfusion-transmitted malaria by testing blood donations from donors at risk of malaria exposure. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of an Eli Lilly emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for treating Covid-19. Lilly requested the revocation after telling FDA that all lots of bamlanivimab and etesevimab manufactured and labeled for use under the EUA have expired,
FDA Policy/General
Federal Register notice: FDA is making available two International Council for Harmonization final guidances entitled “Q2(R2) Validation of Analytical Procedures” and “Q14 Analytical Procedure Development.” Q2(R2) provides a general framework for the principles of analytical procedure validation, including validation principles that cover the analytical use of spectroscopic data.
FDA Policy/General
Federal Register notice: FDA is renewing its Gastrointestinal Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 3/3/2026. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing its decision to deny a request for a hearing on a CDER-proposed decision to not approve a Vanda Pharmaceuticals supplemental NDA for Hetlioz (tasimelteon) capsules, 20 milligrams (mg) for treating jet lag disorder. “Based on a review of the parties’ submissions, FDA finds
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Applications for FDA Approval To Market a New Drug — 21 CFR Part 314.” The collection supports statutory and regulatory authorities that govern new drugs. The agency is revising Form FDA 3898 (Drug Master File) and the accompanying
FDA Policy/General
Senate and House appropriators have released a joint spending bill agreement for fiscal year 2024 that would provide FDA with a $160 million (2.4%) budget boost over last year. The bill proposes $6.7 billion for the agency, which includes $3.5 billion in discretionary spending and $3.2
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Data to Support Drug Product Communications as Used by the Food and Drug Administration.” The collection supports agency outreach and other proactive communication efforts by recommending the evaluation of communication messages and supporting materials in advance of
FDA Policy/General
Federal Register notice: FDA is announcing a 5/16 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations on the selection of strains to be included in the 2024–2025 formula for Covid–19 vaccines. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled ‘‘Clinical Pharmacology Considerations for Antibody-Drug Conjugates (ADC),’’ which provides recommendations for developing antibody-drug conjugates. The document addresses the agency’s current thinking regarding clinical pharmacology considerations and recommendations for ADC development programs, including bioanalytical methods, dose selection
FDA Policy/General
Federal Register: FDA is announcing a publication containing modifications the agency is making to the list of standards it recognizes for use in premarket reviews. This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 061” is intended to assist manufacturers who elect to declare conformity with