FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Predetermined Change Control Plans for Medical Devices.” The agency says such plans contain documentation describing what modifications will be made to a device and how the modifications will be assessed. The guidance provides FDA’s current thinking on a
Biologics
FDA has approved and given emergency use authorization for updated monovalent Covid-19 mRNA vaccines produced by Moderna and Pfizer. An agency statement says the updated 2024-2025 vaccines are formulated to correspond to the Omicron variant KP-2 strain of SARS-CoV-2. Updated Covid vaccines more closely target
Devices
Defibtech has begun a Class 1 recall of its RMU-2000 ARM XR Chest Compression Devices due to a motor problem that may cause them to stop compressions. “The use of affected products may cause serious adverse health consequences, including patient injuries, delay of therapy and death due to a
Drugs
FDA has granted Wex Pharmaceuticals a fast-track designation for Halneuron (tetrodotoxin for injection), an alternative to narcotics and opioids for treating chemotherapy-induced neuropathic pain (CINP). The drug is currently being evaluated in a Phase 2B clinical trial for CINP, according to the company. Wex says the small molecule
Drugs
FDA has published a new batch of product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDA approvals. The list of 14 new and 54 revised PSGs contains: * 41 PSGs for products with no approved ANDAs, including 26 complex products; * 33 PSGs (8 new
Devices
FDA has published a guidance, FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act, establishing procedures for submitting, reviewing, and responding to requests for information regarding the class in which a medical device has been classified or the requirements applicable
Drugs
Liquidia Corp. has filed a lawsuit against FDA over the agency’s recent decision to grant United Therapeutics Corp. (UTC) an additional three-year exclusivity period for Tyvaso DPI (treprostinil), which blocks Liquidia’s Yutrepia (treprostinil) from entering the market before 5/23/2025. Treprostinil is indicated for treating pulmonary
Devices
FDA has approved an Abbott PMA supplement to modify the labeling on its HeartMate 3 left ventricular assist device (LVAD, or heart pump) to eliminate aspirin as part of routine patient management. The company notes that blood thinners have routinely been used by patients receiving LVADs to reduce the risk
Devices
FDA has published a draft guidance, Predetermined Change Control Plans for Medical Devices, with the agency’s current thinking on a policy for predetermined change control plans (PCCPs) and recommendations on the information to include in a marketing submission for a device. The document defines PCCPs as the documentation describing
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance on considerations in demonstrating interchangeability with a reference product is “a helpful step to provide further transparency into FDA’s evolving approach regarding the need for a switching study or studies to support an interchangeability determination for a
Drugs
FDA has issued Regeneron Pharmaceuticals a complete response letter on its BLA for linvoseltamab in relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. “The sole approvability issue identified is related to findings from a pre-approval inspection at a third-party fill/
Drugs
FDA has published an International Council for Harmonization guidance, E11A Pediatric Extrapolation, to provide recommendations for and promote 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
Devices
FDA has given 510(k) clearance to Nanox for its HealthCCSng V2.0 advanced artificial intelligence cardiac solution that helps identify patients at high risk of coronary artery disease. A company statement says the device uses medical imaging data from routine non-gated, non-contrast CT scans that include the
FDA Policy/General
The FDA Bioresearch Monitoring (BIMO) FY 2023 metrics report shows there were 1,073 BIMO inspections across the five FDA Centers. CDER had by far the largest number of inspections at 779, with 141 through CDRH, 126 through CBER, and 26 through CVM. The report also gives common inspection observations
Drugs
The United States Court of Appeals for the DC Circuit has granted a Novartis motion to stay FDA’s approval of MSN Laboratories’ generic version of Novartis’s Entresto (sacubitril/valsartan) until it rules on the matter, which is related to a labeling carve-out dispute. In July, Novartis (see
Devices
An 8/20 New York Times investigative article exposes alleged conflicts of interest in retiring CDRH director Jeff Shuren’s regulatory role and the legal work done by his wife Allison for the same industry at the iconic industry law firm of Arnold & Porter, sometimes apparently overlapping into the
FDA Policy/General
Federal Register notice: FDA has determined that Horizon Therapeutics’ Pennsaid (diclofenac sodium) topical solution 2% was not withdrawn due to safety or effectiveness issues. The determination means that FDA will continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. The nonsteroidal
FDA Policy/General
Federal Register notice: FDA makes available a final guidance entitled “Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA.” The document provides recommendations to industry on product-specific guidance (PSG) meetings between FDA and an ANDA applicant. It also addresses information on requesting and conducting PSG meetings (i.
Biologics
FDA has approved a Johnson & Johnson BLA for Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. The
Devices
FDA has cleared a SI-Bone 510(k) for the iFuse Torq TNT Implant System for pelvic fragility fracture fixation and sacroiliac joint fusion. The device comprises a porous threaded implant with lengths capable of spanning the posterior pelvis, passing through the ipsilateral ilium, sacrum, and into the contralateral ilium,
Drugs
The Federal Trade Commission (FTC) has submitted a comment to FDA expressing its support for a draft guidance removing a prior recommendation that a biosimilar drug applicant had to submit clinical switching studies to demonstrate the biosimilar’s interchangeability with its reference drug. Under the FDA draft, applicants can submit
Devices
The Government Accountability Office (GAO) says FDA has faced challenges in its efforts to establish an active postmarket surveillance system for medical devices. The report identifies these steps that the agency has taken: * establishment in 2016 of a coordinating center to partner with FDA to organize a network of data