Drugs
FDA is extending by three months its review of an Apellis Pharmaceuticals NDA for intravitreal pegcetacoplan based on new data submitted that the agency has considered a major amendment. The drug has a proposed indication of treating geographic atrophy (GA) secondary to age-related macular degeneration. The data submission includes
Drugs
Twenty-one state attorneys general (AGs) led by California's Rob Bonta are urging FDA to approve over-the-counter (OTC) birth control pills. In an 11/4 letter to FDA commissioner Robert Califf, the AGs stress the need to improve access to birth control for millions of people
Drugs
FDA and academic researchers say there are steps that can be taken to support the inclusion of transgender people in oncology trials. Writing in the Journal of Clinical Oncology, the authors say at least 1.6 million transgender people are living in the U.S. and more than 400,000
Drugs
FDA’s Pharmaceutical Science and Clinical Pharmacology Advisory Committee 11/2 voted 9 to 0 to recommend that CDER move forward with developing and implementing its long-planned Quality Management Maturity (QMM) program. “QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve
Drugs
FDA commissioner Robert Califf says that over the past 10 years FDA and state regulators “have worked hard to strengthen our oversight of drug compounding.” Speaking on 11/1 at the 11th Annual Intergovernmental Working Group Meeting on Drug Compounding, Califf recognized that it has been 10 years since an
Drugs
FDA says it has added updated definitions of the face-to-face format for formal meetings with the agency to the PDUFA 7 and BsUFA 3 Web pages. The new definitions are from the PDUFA and BsUFA commitment letters and clarify that a face-to-face meeting “includes in-person
Drugs
FDA says PDUFA 7 includes an agency commitment to advancing modern approaches to enhance the efficiency of the drug development and review process, such as model-informed drug development (MIDD). The agency says it intends to build on the MIDD paired meeting pilot by continuing to advance and integrate the
Drugs
GSK has stopped enrollment early due to positive results in two Phase 3 trials evaluating gepotidacin, an investigational drug for uncomplicated urinary tract infection (uUTI). The early stoppage comes on the recommendation of an independent data monitoring committee, which conducted a pre-specified interim analysis of efficacy and safety data
Drugs
The FDA Health Informatics Team, the National Institutes of Health Center for Advancing Translational Sciences, and the European Medicines Agency have collaborated to create the Global Substance Registration System (GSRS). An FDA Global Update says the new system will enable the efficient and accurate exchange of information on the substances
Drugs
FDA has published a guidance, Cross Labeling Oncology Drugs in Combination Regimen, with the agency’s current recommendations about including relevant information in the labeling for oncology drugs approved for use in a combination regimen, including important considerations for cross labeling of the drugs. The document says a combination regimen
Drugs
FDA says it is temporarily exercising additional enforcement discretion for certain clozapine REMS requirements to ensure continuity of care for patients taking the drug. An agency notice says FDA is aware that healthcare professionals and patients continue to experience ongoing difficulties with the clozapine REMS program, including issues with access
Drugs
The Department of Justice (DoJ) says an Ohio doctor and a former drug company representative have each pleaded guilty to one count of conspiracy to solicit, receive, offer, and pay healthcare kickbacks. A department statement says Deepak Raheja, Hudson, OH, a doctor specializing in psychiatry and neurology with a practice
Drugs
Radius Health has submitted a supplement to its 4/22 petition regarding its Tymlos (abaloparatide) injection. The supplement asks that FDA take these actions, in addition to those requested in the original petition: * refuse to grant an A-therapeutic equivalence rating to any ANDA or 505(b)(2) NDA referencing
Drugs
Six Republican lawmakers are urging FDA commissioner Robert Califf to update them about an ongoing delay to review Florida’s proposed Canadian Prescription Drug Importation Program. A rule advanced by the Trump Administration allows states to implement import programs as long as FDA approves their programs. Florida’s Agency for
Drugs
Eli Lilly says it appreciates FDA’s efforts to better standardize safety data and analysis. Commenting on an agency docket on Advancing Premarket Safety Analytics, Lilly asks that the agency “support efforts in ensuring the document describes a customized approach, which may bring the necessity for updating some terms with
Drugs
An FDA 10/28 Warning Letter says Amazon.com, Seattle, WA, is distributing three products that violate the Federal Food, Drug, and Cosmetic Act. The letter says the firm is responsible for introducing the unapproved drugs into interstate commerce through the Fulfillment by Amazon service. The letter gives examples of
Drugs
A 4/13-4/22 FDA inspection at Sovereign Pharmaceuticals, Fort Worth, TX, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other violations. A 10/5 Warning Letter says specific violations were: * failing to establish adequate written procedures for production and process controls designed
Drugs
The Biotechnology Innovation Organization (BIO) says it appreciates that a draft guidance developed by the International Council for Harmonization (ICH) explains how pediatric extrapolation can be applied practically to support the safety and efficacy of a product in pediatric populations in a manner that will advance pediatric drug development globally.
Drugs
FDA has issued a revised draft guidance, Expanded Access to Investigational Drugs for Treatment Use Questions and Answers, with updated information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of the agency’s regulations on expanded access to investigational drugs for treatment use under an
Drugs
A 10/28 citizen petition submitted by the Hyman, Phelps & McNamara law firm asks FDA to refuse to approve any NDA seeking approval of a conventional Technetium-99m (Tc-99m) generator or Tc-99m product that relies on neutron capture technology given the advances in Tc-99m production that
Drugs
A 3/22-4/4 FDA inspection at the Lupin Limited drug manufacturing facility in Maharashtra, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 9/27 Warning Letter says the specific deviations were: * failing to establish adequate written procedures
Drugs
FDA researchers say the use of expedited drug development and review programs increased from 2008 to 2021 and is likely to continue increasing. Writing in a JAMA Network open-access article, the researchers say they wanted to learn how often the accelerated approval, breakthrough therapy, fast track, and priority review