Drugs
The CDER Office of Surveillance and Epidemiology (OSE) has developed and is using an Information Visualization Platform (InfoVIP) incorporating artificial intelligence (AI) and advanced visualizations to support OSE safety reviewers as they examine data or content to discover deeper insights, make predictions, or generate recommendations to support postmarket safety surveillance.
Drugs
FDA has announced two new pilot programs that the International Coalition of Medicines Regulatory Authorities (ICMRA), of which the agency is a member, is spearheading and seeking industry participants — one on collaborative assessments of chemistry, manufacturing and control (CMC) related post-approval changes and the other on hybrid inspections. FDA
Drugs
Gilead Sciences has resubmitted an NDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for treating HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. The resubmission addresses chemistry, manufacturing and controls issues raised in a February-issued complete response letter (see
Drugs
FDA has issued a complete response letter for a Spero Therapeutics NDA for tebipenem HBr oral tablets to treat adult patients with complicated urinary tract infections, including pyelonephritis. The agency had previously set 6/27 as the PDUFA action date for the NDA. The company says FDA found that the
Drugs
An 11/1-11/18/21 FDA inspection at the Fagron, Inc., drug manufacturing facility in St. Paul, MN, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 6/14 Warning Letter says specific violations were: * failing to perform repackaging of API under
Drugs
FDA has released a proposed rule that broadens options for drug companies seeking to market a nonprescription drug product. The agency is proposing use of an “additional condition” for potential nonprescription products when labeling alone is not sufficient to ensure that the consumer can appropriately self-select and use a
Drugs
FDA has placed a partial clinical hold on a Nuvation Bio Phase 1 dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2-advanced breast cancer and metastatic castration-resistant prostate cancer. The trial began enrolling patients 12/2020, but in recent months as higher
Drugs
A new CDER Office of New Drugs (OND) annual report highlights some of its work with sponsors to advance innovative clinical trial designs. “These innovations enabled the launch of new drug development programs, the inclusion of previously under-represented patient populations in clinical trials that might otherwise have been impracticable,
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FDA has placed a clinical hold on Astellas Pharma’s FORTIS Phase 1/2 trial following a serious adverse event (SAE) report of peripheral sensory neuropathy in one of the trial participants. FORTIS is evaluating AT845, an investigational adeno-associated virus gene replacement therapy in adults with Late-Onset Pompe
Drugs
FDA has made available a draft guidance entitled “Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics.” The document provides recommendations for certain evaluations including pharmacokinetic, pharmacodynamic, and safety assessments during oligonucleotide therapeutic development, including: (1) characterizing the potential for QTc interval prolongation, (2) performing immunogenicity risk assessments, (3) characterizing
Drugs
Amryt says it will file an FDA formal dispute resolution request over a complete response letter it received in February for its NDA for Filsuvez (oleogel-S10), indicated for treating cutaneous manifestations of dystrophic and junctional epidermolysis bullosa (EB). The rare genetic skin disease, Amryt says, is characterized by extremely
Drugs
Former Pharmatech CEO Raidel Figueroa has pled guilty to conspiring to defraud FDA, falsifying records in an agency investigation, obstructing proceedings before FDA, and distributing adulterated drugs, according to a Justice Department release. The drug and dietary supplement manufacturer previously operated in Broward County, FL. The case dates to a
Drugs
FDA has made available a guidance entitled “Providing Regulatory Submissions in Alternate Electronic Format.” The document provides recommendations on an alternate electronic format for submissions that receive an exemption or a waiver from filing in the standard electronic common technical document (eCTD) format under Section 745A(a) of the FD&
Drugs
AbbVie has submitted an sNDA to FDA for a new indication for its Qulipta (atogepant) as a preventive treatment for chronic migraine. The company says the submission was based on the Phase 3 PROGRESS chronic migraine study evaluating Qulipta in adults who met the primary endpoint of statistically significant reduction
Drugs
FDA has published a draft guidance, Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination, describing methods, facility design elements, and controls that are important in preventing drugs from being cross-contaminated with compounds containing a beta-lactam ring. The document also provides information about the relative
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New York University bioethics professor Arthur Caplan says that among all the efforts to increase clinical trial diversity, what’s missing is a clear explanation of why it is so important. In a Stat First Opinion post, Caplan reviews some recent announcements from FDA and other stakeholders calling for greater
Drugs
FDA has published its “Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis,” a five-year plan developed to meet a requirement in the Accelerating Access to Clinical Therapies for ALS Act. The document says it will advance innovation that promotes and accelerates medical product development to treat rare
Drugs
FDA has granted Novartis accelerated approval for Tafinlar (dabrafenib) plus Mekinist (trametinib) for treating patients six years of age and older with unresectable or metastatic solid tumors with a BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options. “The combination of dabrafenib and
Drugs
FDA has published a guidance, Assessing the Effects of Food in INDs and NDAs—Clinical Pharmacology Considerations, with recommendations for sponsors planning to conduct food-effect (FE) studies for orally administered drug products under INDs to support NDAs and supplements to those applications. The document revises and replaces part of
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FDA has published a draft guidance, Considerations for Rescinding Breakthrough Therapy Designation, explaining how, during the evaluation of a drug development program, the agency may consider whether to rescind a breakthrough therapy designation. The document says the guidance is consistent with and supplements the information on breakthrough therapy designation included
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University of Illinois at Chicago psychiatry professor Anand Kumar says FDA should “scrutinize the accelerated [approval] program rigorously to ensure that surrogate endpoints are clinically meaningful before approving drugs under this mechanism.” Writing in an online opinion column for The Hill, Kumar traces the history of the accelerated approval program
Drugs
The Vermont federal court has permanently enjoined Edge Pharm, a Colchester, VT, compounding pharmacy, from distributing drugs unless they are manufactured in compliance with the Federal Food, Drug, and Cosmetic Act. A Department of Justice statement says the government alleged that the pharmacy and its owners manufactured and distributed adulterated