Drugs
Four stakeholders are raising technical questions, concerns, requests for clarification, and comments on an FDA draft guidance on quality considerations for topical ophthalmic drug products. In its comment, the Consumer Healthcare Products Association says it respects the need for the guidance, especially given recent global concerns about contaminated ophthalmic drug
Drugs
FDA has approved a U.S. WorldMeds NDA for eflornithine for reducing the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. Approval was based on data from two
Devices
Sens. Richard Durbin (D-IL) and Richard Blumenthal (D-CT) are asking the Government Accountability Office (GAO) to update its 2011 report recommending that FDA enhance its oversight of medical device recalls. The senators say an update is needed in light of the dramatic increase in overall device recalls, especially
Drugs
FDA says Novid Group in Northridge, CA, is distributing an over-the-counter combination antihistamine and nasal decongestant, novid Nasal Spray, through its Web site. A 12/7 Warning Letter says the product is illegally distributed because it is an unapproved new drug that also is misbranded. The letter contains
Drugs
Vertex Pharmaceuticals says it will advance selective NaV1.8 inhibitor VX-548 into pivotal Phase 3 studies after it discusses with FDA and other regulators “positive results” from its Phase 2 dose-ranging study in people with painful diabetic peripheral neuropathy (DPN). “Treatment with all doses of VX-548 resulted
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Advanced Manufacturing Technologies Designation Program.” The document encourages the early adoption of advanced manufacturing technologies (AMTs) that can benefit patients by improving manufacturing and supply dependability and optimizing product development times. It says AMTs can directly improve product quality
FDA Policy/General
Federal Register notice: FDA is establishing the Genetic Metabolic Diseases Advisory Committee, and its duration is two years from the date the charter is filed. The committee can be renewed if the agency determines that it is in the public interest. The nine-voting-member panel is intended to review
FDA Policy/General
HHS has opened its review of FDA’s efforts to create a unified Human Foods Program (HFP) and new Office of Regulatory Affairs (ORA) model. An agency statement says the proposed reorganization would strengthen its ability to oversee and protect the human food supply and other products it regulates. New
Drugs
The Senate HELP Committee has passed the Ensuring FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act that would allow the agency to deny an NDA for an opioid analgesic based on the drug not being clinically superior to other commercially available drugs. The measure is sponsored
FDA Policy/General
Nine Republican senators are urging FDA to increase its foreign inspections of medical product manufacturing facilities. In a 12/13 letter to FDA commissioner Robert Califf, the lawmakers cite the agency’s own data and ask why it completed “only eight inspections of Chinese drug manufacturers and zero of Chinese
Biologics
FDA has accepted for priority review an Amgen BLA for tarlatamab for treating adult patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. The agency has set a review action target date of 6/12/2024. The BLA is based on data
Devices
AdvaMed is raising issues with FDA’s 9/2023 issuance of three “impactful and cross-cutting draft guidance documents related to the 510(k) program.” In its comment on the CDRH FY 2024 proposed guidance development document, the association notes that FDA said the guidances were developed in response to
Drugs
Syndax Pharmaceuticals says it will file later this month an NDA for revumenib, a first-in-class menin inhibitor for treating patients with relapsed/refractory (R/R) KMT2A-rearranged (KMT2Ar) acute myeloid leukemia (AML) and acute lymphoid leukemia (ALL). The decision to file the submission is based on “positive data”
FDA Policy/General
Federal Register notice: FDA is making available a summary of the comments received for the “Methodological Challenges Related to Patient Experience Data; Request for Information and Comments” notice published 5/2. on May 2, 2023. The input received is intended to help FDA plan two public workshops focused on methodological
Drugs
The U.S. Supreme Court has agreed to hear arguments in an appeal of the 5th Circuit Court of Appeals decision (Danco Laboratories v. Alliance For Hippocratic Medicine, et al.) that sharply restricts distribution of the chemical abortion pill mifepristone (Danco’s Mifeprex). The justices wiil hear one hour of
Drugs
FDA says it is creating a new Genetic Metabolic Diseases Advisory Committee to give the agency independent knowledgeable advice and recommendations on technical, scientific, and policy issues around medical products for genetic metabolic diseases. An agency statement says committee members “will evaluate evidence on key issues about the applications brought
Drugs
Public Citizen says FDA should quickly highlight the risk of botulism in the labeling of all seven approved Botox (onabotulinumtoxinA) and related drugs. The advocacy group petition says the agency also should remove what it says are misleading promotional claims from the Botox and Botox Cosmetic labels. A Public Citizen
Drugs
FDA has published a draft guidance, Advanced Manufacturing Technologies Designation Program, with recommendations for persons and organizations interested in participating in the agency’s Advanced Manufacturing Technologies (AMT) Designation Program, which is intended to facilitate the development of drugs manufactured using an AMT that has been designated under the program.
Devices
Utah-based medical device company Dolor Technologies has entered into a settlement agreement with the U.S. government to resolve Dolor’s civil liability relating to a device it sold for treating migraines. “This resolution requires Dolor to make monetary payments to the U.S. based upon its ability to
Drugs
FDA has published a draft guidance, Clinical Pharmacology Considerations for Peptide Drug Products, with recommendations to assist industry in developing peptide drug products. When finalized, the document says, it will describe the agency’s current thinking about the impact of clinical pharmacology considerations, including hepatic impairment, drug-drug interactions, QTc
Drugs
A new FDA guidance, Drug-Drug Interaction Assessment for Therapeutic Proteins, lays out a risk-based approach to determining when drug-drug interaction (DDI) studies are needed for therapeutic proteins. In a Guidance Recap Podcast, CDER Office of Clinical Pharmacology policy lead Qin Sun says that several aspects should be
FDA Policy/General
Federal Register notice: CDER and CBER are announcing that support begins for version 2.0 of the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model version 3.4 of the CDISC Study Data Tabulation Model Implementation Guide, and version 1.0 of the Standard for Exchange of Nonclinical