FDA Policy/General
Senate and House appropriators have released a joint spending bill agreement for fiscal year 2024 that would provide FDA with a $160 million (2.4%) budget boost over last year. The bill proposes $6.7 billion for the agency, which includes $3.5 billion in discretionary spending and $3.2
Devices
FDA has cleared a Dexcom 510(k) for the company’s Stelo Glucose Biosensor System, which the agency says is the first over-the-counter continuous glucose monitor (CGM). The integrated CGM is intended for “anyone 18 years and older who does not use insulin, such as individuals with diabetes
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Data to Support Drug Product Communications as Used by the Food and Drug Administration.” The collection supports agency outreach and other proactive communication efforts by recommending the evaluation of communication messages and supporting materials in advance of
Drugs
FDA has extended by three months its review of a Zevra Therapeutics NDA resubmission for arimoclomol, an investigational oral treatment for Niemann-Pick disease Type C (NPC). The new user fee review action target date is 9/21, according to the agency, which also re-affirmed its intent to present
Biologics
FDA has approved Hugel’s Letybo (botulinum toxin), a neurotoxin for treating moderate-to-severe glabellar (frown) lines in adults. Approval was based on data from three Phase 3 trials that enrolled more than 1,000 subjects in the U.S. and Europe (BLESS I NCT02677298, BLESS II NCT02677805 and
FDA Policy/General
Federal Register notice: FDA is announcing a 5/16 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations on the selection of strains to be included in the 2024–2025 formula for Covid–19 vaccines. To view the notice, click here.
Drugs
FDA has lifted a partial clinical hold on Iovance Biotherapeutics’ IOV-LUN-202 trial investigating the company’s LN-145 TIL cell therapy in non-small cell lung cancer (NSCLC). “In collaboration with the FDA and an independent data monitoring committee, Iovance developed additional safety measures and monitoring,” the company
Drugs
SpringWorks Therapeutics has begun a rolling NDA for mirdametinib, an investigational MEK inhibitor for treating pediatric and adult patients with neurofibromatosis Type 1-associated plexiform neurofibromas (NF1-PN). The rare genetic disorder is caused by mutations in the NF1 gene. “The clinical course of NF1 is heterogeneous and manifests in
Biologics
CBER has cited Oregon Medical Centers in an untitled letter over claims it is making on social media sites Facebook and Youtube about its cellular product derived from a human umbilical cord. The letter takes issue with the medical facility referring to its product as “regenerative medicine,” “regenerative cells,” “regenerative
Devices
FDA has approved a Boston Scientific PMA for the AGENT Drug-Coated Balloon (DCB), indicated for treating coronary in-stent restenosis (ISR) in patients with coronary artery disease. ISR is the obstruction or narrowing of a stented vessel by plaque or scar tissue. The paclitaxel-coated balloon catheter is designed
Biologics
FDA is affirming its regulation of “fresh allograft heart valves” in a just-posted letter to healthcare professionals. The letter addresses recent questions the agency has received about the regulatory status of the allograft heart valves used in a procedure commonly referred to as “partial heart transplantation,” which involves transplantation
Drugs
Endo Health Solutions has agreed to plead guilty in federal court and pay over $2 billion in penalties to resolve criminal and civil investigations related to the company’s sales and marketing of the opioid drug Opana ER with INTAC, according to a Justice Department release. “The criminal resolution includes
Drugs
FDA has refused to grant a hearing request by Vanda Pharmaceuticals on a stalled supplemental NDA for Hetlioz (tasimelteon) capsules, 20 milligrams (mg) for treating jet lag disorder. “Based on a review of the parties’ submissions, FDA finds that there is no genuine and substantial issue of fact justifying a
Devices
FDA has classified as Class 1 a Datex-Ohmeda recall of its EVair 03 (Jun-air) air compressor (model numbers: 1609000 and 1609002) after the company says it became aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air) optional compressors are used with the CARESCAPE
Drugs
FDA has approved an Allecra Therapeutics NDA for Exblifep (cefepime/enmetazobactam) for treating complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older. For obtaining approval, the agency granted to company a five-year marketing exclusivity extension under the Generating Antibiotic Incentives Now Act. The approval was
Devices
FDA has updated a Class 1 recall (correction) of Megadyne Medical Products’ Mega Soft patient return electrode models. An agency notice says the recall was to update the instructions for use and product labeling to restrict the use of the device to patients aged 12 years and older. “Megadyne has
Drugs
FDA has released a draft guidance on “Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards.” The document provides recommendations on provisions in HHS’ regulations on protecting human subjects in clinical trials and it addresses the presentation of key information and includes recommendations
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled ‘‘Clinical Pharmacology Considerations for Antibody-Drug Conjugates (ADC),’’ which provides recommendations for developing antibody-drug conjugates. The document addresses the agency’s current thinking regarding clinical pharmacology considerations and recommendations for ADC development programs, including bioanalytical methods, dose selection
FDA Policy/General
Federal Register: FDA is announcing a publication containing modifications the agency is making to the list of standards it recognizes for use in premarket reviews. This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 061” is intended to assist manufacturers who elect to declare conformity with
Drugs
FDA has granted full approval to Johnson & Johnson’s Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by
Devices
CDRH has posted an online statement updating its work in providing information to patients and providers about the safety risks of breast implants and regulatory actions involving implants and their removal. In the statement, CDRH Office of Surgical and Infection Control Devices director Binita Ashar cites a recent article in
Drugs
FDA has published a guidance, Clinical Pharmacology Considerations for Antibody-Drug Conjugates, with recommendations to assist industry and other parties involved in the development of antibody-drug conjugates (ADC) with a cytotoxic small-molecule drug or payload. The document addresses the agency’s current thinking about clinical pharmacology considerations and