Drugs
Alvogen has recalled two lots of fentanyl transdermal system 12 mcg/h transdermal patches due to a labeling error. “A small number of cartons labeled 12 mcg/h fentanyl transdermal system patches contained 50 mcg/h patches,” a recall notice says. “The 50 mcg/h patches that were included in
Drugs
FDA has announced that the National Academies of Science, Engineering, and Medicine (NASEM) is conducting a study to examine the clinical utility of treating patients with compounded “bioidentical hormone therapy” products, such as progesterone and testosterone. NASEM is expected to provide a report evaluating the available scientific evidence relating to
Drugs
FDA has accepted a Molecular Templates IND application for MT-5111, an engineered toxin body (ETB) targeting HER2-positive solid tumors. The company expects to start dosing in a Phase 1 study in relapsed/refractory patients with HER2-positive solid tumors in the third quarter. Molecular Templates describes MT-5111
FDA Policy/General
Assessment of Quantitative Imaging Devices Guide Federal Register notice: FDA makes available a draft guidance entitled “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions.” 04/19/2019 Draft Guide on Nitinol-Containing Medical Devices Federal Register notice: FDA announces the availability of a draft guidance entitled “Technical Considerations
FDA Policy/General
DEVICES FDA has cleared a Bausch & Lomb 510(k) for its frequent replacement silicone hydrogel contact lenses made with MoistureSeal Technology. Medtronic has received FDA PMA approval for its MiniMed 530G with Enlite, an artificial pancreas system with Threshold Suspend automation for people with diabetes 16 and older. The
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Technical Performance Assessment of Quantitative Imaging in Premarket Device Submissions.” The document says that manufacturers preparing premarket submissions for devices that include quantitative imaging functions should provide performance specifications for the quantitative imaging functions, supporting performance data to demonstrate
FDA Policy/General
Federal Register notice: FDA has announced the availability of a draft guidance entitled “Technical Considerations for Non-Clinical Assessment of Medical Devices containing Nitinol.” The document is intended to provide clarity and consistency in recommended non-clinical assessments across a variety of medical devices that contain nitinol. To view the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Bispecific Antibody Development Programs.” The document covers general considerations and recommendations for these programs, as well as regulatory, quality, nonclinical, and clinical considerations in the context of bispecific antibody development programs. It does not discuss development considerations for other
Drugs
FDA has approved a Teva Pharmaceuticals ANDA for the first generic naloxone hydrochloride nasal spray (Adapt Pharma’s Narcan), indicated for stopping or reversing the effects of an opioid overdose. In announcing the approval, FDA also said it is “planning new steps to prioritize the review of additional generic drug
Drugs
Pfizer and Eli Lilly have reported safety concerns with a Phase 3 study comparing tanezumab 2.5 mg and 5 mg with nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with moderate-to-severe osteoarthritis (OA) of the hip or knee. The study, which was designed to evaluate tanezumab’s long-
Drugs
FDA has given approval for MediciNova to proceed with a Phase 2b/3 clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS) patients. If the pivotal trial is successful, data will be used to support a future NDA, according to the company. FDA concurred, it says, on the
Drugs
FDA has approved an Akorn ANDA for a generic copy of Bausch & Lomb’s Lotemax (loteprednol etabonate) ophthalmic suspension, 0.5%, indicated for treating post-operative inflammation following ocular surgery and the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of
Devices
FDA has cleared a Medicrea Group 510(k) for expanded use of its proprietary surgical planning software, UNiD Hub, to integrate a complete database of the company’s implant portfolio to directly simulate and select implants during planning for surgery. “The integration of an implant database with Medicrea’s UNiD
FDA Policy/General
Federal Register notice: FDA has extended the comment period for a 2/26 proposed rule on the regulation of over-the-counter sunscreen monograph products. Comments can now be submitted until 6/27. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has corrected a 2/26 proposed rule on the regulation of over-the-counter sunscreen monograph products. The document was published with formulas that were illegible, and corrections were made to improve its accuracy. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Abbreviated New Animal Drug Applications — Sections 512(b)(2) and (n)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and (n)(1))” (OMB Control Number 0910-0669). To view
FDA Policy/General
Federal Register notice: FDA has determined that Cephalon’s Trisenox (arsenic trioxide) injection, 1mg/mL, was not withdrawn for safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Trisenox is indicated in
Devices
FDA has published a draft guidance, Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions, that, when finalized, will provide detailed recommendations for manufacturers on the information that should be included in PMA, HDE, and 510(k) submissions, IDE applications, and de novo requests for medical devices that include
Drugs
FDA has issued a draft guidance, Bispecific Antibody Development Program, to assist industry and other parties involved in the development of bispecific antibodies. The document covers general considerations and recommendations for bispecific antibody development programs, as well as regulatory, quality, nonclinical, and clinical considerations in the context of bispecific antibody
Devices
FDA has published a draft guidance, Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol, to give the agency’s current thinking on technical considerations specific to devices using nitinol, a commonly used material in the medical device industry. The document says that medical device manufacturers have used
Drugs
Friends of Cancer Research chairperson Ellen Sigal says a recent White House memo requiring Office of Management and Budget (OMB) review of all non-binding guidance documents from all federal agencies “potentially threatens the future of many scientific innovations that could save patients’ lives.” Writing in an op-ed in
Drugs
Mustang Bio has reported positive data from a Phase 1/2 clinical trial of a lentiviral gene therapy for treating newly diagnosed infants under two years old with XSCID, also referred to as SCID-X1 and commonly known as “bubble boy disease.” Under a licensing agreement with St. Jude Children’