Drugs
As House Republicans prepare to advance a right-to-try bill through the Rules Committee process, four former FDA commissioners have issued a brief joint statement opposing the measure. Issued by ex-FDA heads Robert Califf, Margaret Hamburg, Mark McClellan and Andrew von Eschenbach, the statement read: “We as former
Drugs
A new FDA drug approval transparency pilot program has released the first Clinical Study Report (CSR) which provides more background on why the agency recently approved Janssen Biotech’s Erleada (apalutamide), the first treatment for non-metastatic, castration-resistant prostate cancer. The drug was approved last month and it was
Drugs
FDA has accepted a pSivida Corp. NDA for Durasert three-year treatment for posterior segment uveitis. The agency has set a user fee review action target date of 11/5. The submission includes data from two Phase 3 studies that each successfully achieved the primary efficacy endpoint at six months.
Devices
FDA has cleared a Cook Medical 510(k) for the Cellvizio Confocal Laser Endomicroscopy System and the Confocal Miniprobes. “Additional data provided in multiple peer-reviewed medical journals paved the way for this new clearance and indication for the Cellvizio system,” the company says. With the clearance, the device can
FDA Policy/General
Arthritis Drugs Panel to Review Eli Lilly NDA Federal Register notice: FDA announces a 4/23 Arthritis Advisory Committee meeting that will review an Eli Lilly NDA for baricitinib tablets. 03/16/2018 Comments Sought on MedWatch Info Collection Federal Register notice: FDA seeks comments on an information collection extension
Drugs
FDA has approved a Tetra Discovery Partners IND for BPN14770, a novel, selective small molecule inhibitor of the phosphodiesterase type-4D enzyme. The company says its research suggests the drug may be useful in the treating Fragile X Syndrome and possibly other autism spectrum disorders. Tetra plans to initiate a
FDA Policy/General
Federal Register notice: FDA has announced a 4/23 g Arthritis Advisory Committee meeting. Panel members are scheduled to discuss an Eli Lilly NDA for baricitinib tablets, indicated for treating adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The
Drugs
FDA has approved CSL Behring’s Hizentra (immune globulin subcutaneous [human] 20% liquid) as maintenance therapy for chronic inflammatory demyelinating polyneuropathy (CIDP) to prevent relapse of neuromuscular disability and impairment. The approval was based on data from the Phase 3 PATH study, which demonstrated that the percentage of patients experiencing
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “MedWatch: The FDA Medical Products Reporting Program” (OMB Control Number 0910-0291). MedWatch permits the reporting of adverse events, product problems, errors with the use of a human medical product, and evidence of therapeutic failure in clinical
FDA Policy/General
Federal Register notice: FDA has amended a 1/23 notice about a 3/22 Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee meeting to reflect a change in the agenda for the open session of the meeting and to extend the amount of time allotted for the closed
Drugs
Q BioMed has filed with FDA for approval of a new manufacturing facility to make strontium chloride Sr89 injection USP, a non-opioid injectable radiopharmaceutical to relieve cancer bone pain in patients with painful skeletal metastases. In the body, strontium acts similar to calcium, selectively localizing in bone and osteoblastic
Drugs
Bayer has recalled Alka-Seltzer Plus packages that were sold at Walmart, CVS, Walgreens, and certain other stores in the U.S. Affected packages are being recalled because the ingredients on the front sticker may not match the actual product in the carton. “This may lead consumers to ingest a
Drugs
FDA has issued the first report of generic drug quarterly metrics required under the GDUFA 2 user fee amendments. The report shows that at the end of the FY 2018 first quarter, there were 2,055 ANDAs awaiting FDA action. The mean full approval time was 41.7 months and
Drugs
FDA says it is delaying indefinitely the effective date of amendments to the existing medical product “intended use” regulations to give the agency more time to consider comments on the proposal. A Federal Register notice scheduled to be published 3/16 says the action does not delay the effective date
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed collection of information — “Health Care Professional Survey of Professional Prescription Drug Promotion.” The study will examine how health care professionals experience and perceive prescription drug promotion directed to them. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has issued an order exempting from premarket notification 510(k) requirements over-the-counter denture repair kits (product code EBO). The devices comprise material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently to a denture to
Drugs
FDA says the Arthritis Advisory Committee will meet 4/23 to discuss Lilly’s NDA for baricitinib tablets. A Federal Register notice says the company is seeking an indication to treat adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
Drugs
FDA has granted Breakthrough Therapy designation for Janssen’s erdafitinib in treating urothelial cancer. A company statement says the designation is based on data from a multi-center Phase 2 trial of the drug’s efficacy and safety in treating adult patients with locally advanced or metastatic urothelial cancer whose
Devices
FDA has cleared a Royal Philips 510(k) for is ProxiDiagnost N90, a digital radiography-fluoroscopy system. The device provides “high-quality images with premium flat detector technology and the new dynamic Unique image processing,” that allows sequences to be stable and harmonized from the first frame to the end,
Devices
FDA has given 510(k) clearance to DxNow for its ZyMot ICSI and ZyMot Multi Sperm Separation devices. The devices are intended for preparing motile sperm from semen for use in treating infertile couples by intracytoplasmic sperm injection, intrauterine insemination, and in vitro fertilization procedures. They are intended to simulate
Drugs
FDA has placed the Solid Biosciences IGNITE DMD Duchenne Muscular Dystrophy Phase 1/2 clinical trial on a clinical hold following a serious adverse event that occurred in the first patient dosed with SGT-001 in the trial. A company statement says the patient was admitted to the hospital, was
Drugs
FDA says its laboratory analysis shows that United Pharmacy’s glutamine, arginine, and carnitine (GAC) 10/100/200 mg/mL product for injection is degrading before the beyond0use date of six months specified on the product label. An agency notice says it previously reported that the product was labeled as