Drugs
FDA has issued a complete response letter for the Zealand Pharma NDA for glepaglutide to treat short bowel syndrome. The letter says the agency concluded that the NDA did not meet the full requirements for substantial evidence to establish the efficacy and safety of the glepaglutide dose that would be
Drugs
A 6/14-6/26/2024 FDA inspection at Viatris’ Mylan Laboratories drug manufacturing facility in Madhya, Pradesh, India, found multiple violations, including significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 12/19/2024 Warning Letter says specific violations were: * failure to establish and follow
Drugs
FDA says it has added a Boxed Warning to labeling for Astellas’ Veozah (fezolinetant) to highlight the known risk of rare but serious liver injury associated with using the menopause medication. A drug safety notice updates the agency’s 9/12/2024 drug safety communication warning that Veozah, used to
Drugs
An FDA 7/15-7/26/2024 inspection at Sombra Cosmetics in Albuquerque, NM, found current good manufacturing practice (CGMP) regulation violations for finished drugs. A 12/18/2024 Warning Letter says the specific violations were: * failure to establish adequate written procedures for production and process control designed to assure
Drugs
FDA has approved Mesoblast’s Ryoncil (remestemcel-L-rknd), an allogenic bone marrow-derived mesenchymal stromal cell (MSC) therapy indicated to treat steroid-refractory acute graft-versus-host disease in pediatric patients aged two months and older. An agency statement says Ryoncil is the first FDA-approved MSC therapy. The
Drugs
Lexicon Pharmaceuticals says it has made a strategic decision to discontinue launch preparations for its diabetes drug Zynquista (sotaglifozin) and focus solely on its development pipeline. A company statement says the decision to discontinue developing Zynquista was made before the firm received an expected Complete Response Letter from FDA addressing
Drugs
FDA has published the International Council for Harmonization draft M15 guidance, General Principles for Model-Informed Drug Development, with general recommendations for planning, model evaluation, and documentation of evidence derived from model-informed drug development (MIDD). The document says it establishes a harmonized assessment framework, including associated terminology, for MIDD
Drugs
FDA has published a guidance, Advanced Manufacturing Technologies Designation Program, with recommendations to persons and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program. The document says the program facilitates the development of drugs manufactured using an AMT that has been designated as such under the program.
Drugs
FDA has published an International Council on Harmonization guidance, E11A Pediatric Extrapolation, providing recommendations for and promoting international harmonization of the use of pediatric extrapolation to support the development and authorization of pediatric medicines. The document says harmonization of the approaches to pediatric extrapolation should reduce the likelihood of substantial
Drugs
FDA has published the International Council for Harmonization’s draft Good Clinical Practice (GCP) E6(R3) guidance Annex 2. The document says Annex 2 provides additional GCP considerations, focusing on examples of trials that incorporate decentralized elements, pragmatic elements, and/or real-world data. “Annex 2 is not meant to
Drugs
FDA says that when it inspected the Brands International drug manufacturing facility in Newmarket, Ontario, Canada, company officials there limited and delayed the inspection in several ways. A 12/17 Warning Letter says the investigators also identified these current good manufacturing practice (CGMP) regulation violations: * failure to thoroughly investigate any
Devices
A 5/6-5/22/2024 FDA inspection at the Becton Dickinson/CareFusion 303 facility in San Diego, CA, found multiple violations in the firm’s manufacturing of Pyxis Medication Management System medical devices. An 11/22/2024 Warning Letter details the specific violations as: * failure to establish and implement
Drugs
FDA has published a draft guidance, Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices, to assist sponsors, clinical investigators, and institutional review boards (IRBs) in defining, identifying, and reporting protocol deviations in clinical investigations. The document says agency regulations do not include a definition of the term
Devices
FDA says the Boston Scientific 10/10/24 recall that updated instructions for using its POLARx and POLARx FIT cryoblation balloon catheters is Class 1. An agency statement says the company updated the user instructions for the catheters due to a higher than anticipated number of reports of esophageal injury,
Drugs
FDA says it will accept until 2/28 comments on a draft guidance entitled Combined FDA and Sponsor Oncologic Drugs Advisory Committee (ODAC) Briefing Document. A Federal Register announcement says the draft guidance contains recommendations for sponsors on the use and development of a combined version of the ODAC briefing
Drugs
An FDA review of records submitted by Akorn Formulations India Private Limited, a manufacturer of over-the-counter drugs in Hyderabad, Telangana, India, in response to an agency request, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished drugs. A 12/17/2024 Warning Letter says the
Drugs
CDER says it is updating its CDER NextGen Portal to allow Right to Try annual summary submissions for CDER-regulated drugs and biological products. “The manufacturer or sponsor of a CDER-regulated drug or biological product provided under Right to Try should now submit its annual summary through the portal,
Drugs
FDA has released a final guidance entitled “Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH).” The agency notes that patients with NASH fibrosis have unique clinical considerations (e.g., underlying hepatic dysfunction) that can make it a challenge to show an investigational product’
Drugs
FDA is encouraging drug sponsors to use centralized statistical monitoring to help keep an eye on clinical trial integrity issues. Such monitoring has become “increasingly feasible with the advent of computerized systems and the increasing use of electronic records which facilitate remote access to electronic data…,”said CDER Division of
Drugs
Consulting firm McKinsey & Co. has agreed to pay $650 million to settle both criminal and civil investigations into its advisory work with Purdue Pharma and the marketing of its OxyContin opioid. The settlement marks a significant development in the ongoing efforts to hold companies accountable for their contributions to
Devices
FDA has cleared a Zimmer Biomet 510(k) for the OsseoFit Stemless Shoulder System for total shoulder replacement. The company says the device is designed to match the natural humeral (upper shoulder bone) anatomy to optimize anatomical fit while maximizing preservation of healthy bone. The anatomically designed anchor implants feature
FDA Policy/General
The incoming Trump administration is likely to increase FDA enforcement of regulations governing direct-to-consumer (DTC) promotions, according to FDA watchers in a panel discussion at the Food and Drug Law Institute’ annual conference in Washington. Commenting on HHS secretary-nominee Robert F. Kennedy Jr.'s opposition to