Drugs
Three Ropes & Gray attorneys say an FDA 8/15 final guidance on informed consent “illustrates a continuing trend toward modernization of clinical research through adoption of risk-based positions that attempt to reduce administrative burden while maintaining protections for human subjects.” Their online Alert also says FDA gives increased
Drugs
FDA says its 9/1-9/29/22 inspection at a clinical trial site maintained by Angela Stupi in Cranberry Twp., PA, found objectionable conditions for two trials of investigational drugs. The inspection was part of the agency’s Bioresearch Monitoring Program and found that Stupi did not comply with
Drugs
FDA says its Endocrinologic and Metabolic Drugs Advisory Committee will meet 9/21 to review and vote on an Intarcia Therapeutics NDA for ITCA 650 (exenatide in Duros device), a drug/device combination product that was rejected by CDER in 2021 as an adjunct to diet and exercise to improve
Drugs
The industry-based Council for Federal Cannabis Regulation (CFCR) says FDA can and should regulate cannabidiol (CBD) and cannabinoid products through its enforcement discretion powers and enforcement policy. In a response to a request for input on cannabis regulation from the Senate HELP Committee and the House Committee on Energy
Drugs
FDA has issued a warning against using Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair due to bacterial or fungal contamination. “Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection,” the
FDA Policy/General
Federal Register notice: FDA is extending the comment period for a 7/14 notice that announced the availability of a draft guidance entitled “Manufacturing Changes and Comparability for Human Cellular and Gene Therapy (CGT) Products.” The document’s purpose is to share the agency’s current thinking on (1) management
FDA Policy/General
Federal Register notice: FDA is announcing an 11/29-30 public workshop entitled “Workshop to Enhance Clinical Study Diversity.” The event is intended to solicit input from participants on increasing the enrollment of historically under-represented populations in clinical studies and encouraging clinical study participation that reflects disease prevalence or
Devices
Draeger Medical has recalled (Class 1) its Carina Sub-Acute Care Ventilators due to the presence of contaminants in the devices’ airpath. “The contaminants exceed acceptable levels if used by pediatric patients for more than 30 days,” a recall notice says, adding that testing found polyether polyurethane in the ventilator’
Devices
Rep. Debbie Dingell (D-MI) has written to FDA commissioner Robert Califf and CDC director Mandy Cohen expressing concern about an outbreak of tuberculosis (TB) linked to the implantation of contaminated bone graft material supplied by Aziyo Biologics in Silver Spring, MD. In an 8/17 letter, Dingell said a
Drugs
AstraZeneca says an FDA draft guidance on efficacy endpoints for clinical trials investigating antidiabetic drugs and biological products, when combined with a 2020 guidance, appears to cover substantially less material than the 2008 guidance it replaces. In a comment letter, the company suggests that the agency consider including in the
Drugs
Lilly says its Retevmo (selpercatinib) met the primary endpoint of progression-free survival in the LIBRETTO-531 study evaluating the drug versus doctors’ choice of approved multikinase inhibitors cabozantinib (Exelixis’ Cabometyx) or vandetanib (Sanofi’s Caprelsa) as an initial treatment for patients with advanced or metastatic rearranged during transfection (RET)
Devices
FDA has cleared a Welldoc 510(k) for its diabetes digital health device, BlueStar, which is intended to provide bolus insulin dose recommendations based on the most recent glucose reading and rate of change from a compatible continuous glucose monitoring (CGM) device. The company says the BlueStar feature is being
Drugs
FDA has granted Nexcella an orphan drug designation for NXC-201 for treating multiple myeloma. The next-generation BCMA-targeted CAR-T cell therapy is currently being evaluated in the Phase 1b/2a clinical trial called NEXICART-1 (NCT04720313), the company says. To date, over 50 patients have been dosed,
Drugs
FDA says Amazon and Walmart are illegally distributing unapproved new drug products intended to treat molluscum contagiosum. The agency issued 8/18 Warning Letters to each company. The Walmart letter says the company’s Web site offers the Naturasil Molluscum Treatment Kit. FDA says it purchased the kit from the
Devices
A 5/15-5/16 FDA inspection at King Systems Corp., doing business as Ambu, Inc., in Noblesville, IN, found that the company is a manufacturer of the King LTS-D branded supraglottic airway with gastric access lumen. An 8/16 Warning Letter says the device is adulterated because Ambu
Drugs
FDA has lifted a clinical hold against a Fulcrum Therapeutics IND for FTX-6058 for the potential treatment of sickle-cell disease (SCD). The hold was ordered 2/23 based on preclinical data previously submitted in 4/2022, 10/2022 and 12/2022, Fulcrum says, adding that non-clinical and
FDA Policy/General
Federal Register notice: FDA is announcing the availability of additional draft and revised draft product-specific guidances for generic drug developers. The guidances provide product-specific recommendations on, among other things, bioequivalence study designs to support ANDAs. To view the notice, click here.
Drugs
Metacel Pharmaceuticals is petitioning FDA to require all sponsors of generic forms of its Ozobax (baclofen) oral solution to conduct and provide the same amount of safety data as the agency asked Metacel to perform in support of the supplemental approval of Ozobax. The petition specifically asks FDA to: * require
Drugs
Rep. Jeff Duncan (R-SC) says FDA’s proposed Human Foods Program reorganization could adversely affect its regulation of dietary supplements. The agency has proposed creating an Office of Food Chemical Safety, Dietary Supplements, and Innovation, eliminating the current separate Office of Dietary Supplement Programs that now regulates the products.
Biologics
FDA has approved a new indication for Pfizer’s Abrysvo (respiratory syncytial virus vaccine) for use in pregnant individuals to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in infants from birth through six months of age. An agency statement says Abrysvo is approved for use
Devices
FDA has cleared a Nurami Medical 510(k) for its electrospun nanofiber-based product, ArtiFascia Dura Substitute, a resorbable dura mater repair graft. The company says neurosurgeries require replacing the dura mater, which protects the brain and cerebrospinal fluid (CSF). ArtiFascia combines two layers of electrospun nanofibers, it says, that
FDA Policy/General
FDA commissioner Robert Califf says he and the agency are spending way too much time on addressing continuing drug shortages, to the tune of about 200 shortages, or what he calls “plugging holes,” each year. “I did not come back to FDA to spend all my time on the supply