Drugs
Republicans on the House Energy and Commerce Committee say there has been no response from FDA to their 7/18 request for information and documents about the agency’s foreign drug inspection program. In a 12/13 follow-up letter to FDA commissioner Robert Califf, the committee leaders say they
Drugs
The Massachusetts federal court has approved a consent decree of permanent injunction against Pharmasol Corp. and its president Marc Badia for distributing adulterated drugs. An FDA statement says a complaint that was filed with the consent decree by the Department of Justice says the company and Bardia failed to: (1)
Drugs
FDA has placed a clinical hold on three CARsgen Therapeutics clinical trials due to chemistry, manufacturing and controls questions. As a result, trials evaluating CT053, CT041, and CT071 are on hold “pending resolution of the findings following an inspection of the manufacturing site located in Durham, NC,” a company release
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Four stakeholders are raising technical questions, concerns, requests for clarification, and comments on an FDA draft guidance on quality considerations for topical ophthalmic drug products.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
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
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
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”
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.
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
Drugs
A new analysis by Friends of Cancer Research (FOCR) finds that more than half of all oncology drugs approved by FDA in the last decade had a postmarketing requirement (PMR) to obtain better dosing (optimal dose) information. “Traditionally, early-phase oncology clinical trials aimed to identify the maximum tolerated dose
Drugs
MAPS Public Benefit Corp. has filed what it calls the first NDA submission for a psychedelic-assisted therapy, MDMA (midomafetamine capsules), for use in combination with psychological intervention for treating post-traumatic stress disorder (PTSD). Psychological intervention includes psychotherapy, talk therapy, or other supportive services provided by a qualified healthcare
Drugs
America First Legal (AFL) has sued FDA and HHS for “illegally concealing government records related to the suppression of hydroxychloroquine (HCQ) and ivermectin to treat Covid-19.” AFL, which is run by controversial former Trump Administration senior advisor Stephen Miller, filed Freedom of Information Act (FOIA) requests last year to
Drugs
FDA has accepted for review a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) as a daily treatment for heartburn associated with non-erosive gastroesophageal reflux disease (GERD) in adults. The agency has set a user fee review action target date of 7/19/2024. The submission is based on data from
Drugs
FDA has issued a revised final guidance entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.” The document provides recommendations for presenting information that is described as numerically addressing the likelihood or magnitude of a drug’s efficacy or risks. It also outlines
Drugs
FDA has notified isotretinoin manufacturers that they must modify their iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) to minimize the burden on patients, pharmacies, and prescribers. According to a letter sent to registered iPLEDGE REMS sponsors, drug manufacturers have six months to make the following changes: * Remove the requirement that
Drugs
FDA has accepted for review an Ascendis Pharma NDA for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism. In May, FDA issued a complete response letter on the original NDA, citing manufacturing control strategy concerns related to the variability of the delivered dose in the drug/device combination product, according