Drugs
CDER is embracing industry’s use of physiologically based pharmacokinetic (PBPK) modeling as an alternative bioequivalence (BE) approach after approving a Perrigo Pharma ANDA for generic diclofenac sodium topical gel that does not include a comparative clinical endpoint BE study. In a just-published regulatory research post, FDA researchers say
Drugs
A Pharmaceutical Research and Manufacturers of America (PhRMA)-funded study finds that more than half (50.5%) of every $1 spent on brand medicines went to payers, middlemen, providers, and other stakeholders in 2020. Adding to the debate on what to reform in hopes of reducing drug prices for patients,
Devices
FDA has cleared a Becton, Dickinson (BD) 510(k) for the BD Kiestra IdentifA system, which is designed to automate preparation of microbiology bacterial identification testing. The device allows lab technicians to use BD Synapsys informatics to select discrete bacterial colonies from a digital plate image, according to the company.
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should not move forward with a proposed study on text analysis of proprietary name interpretations. The association’s 1/3 comment letter says it is concerned that the “proposed survey will not produce data that will appropriately inform or meaningfully improve
Devices
FDA has cleared a Biolase 510(k) for the EdgePro system for cleaning and disinfection during root canal procedures performed by endodontists. The laser-assisted microfluidic irrigation device uses the company’s Er,Cr:YSGG 2780 nm wavelength laser technology, which was shown to provide debridement, cleaning, and disinfection by
Drugs
FDA has approved an Otsuka America Pharmaceutical and H. Lundbeck supplemental NDA for Rexulti (brexpiprazole) for treating schizophrenia in pediatric patients 13 to 17 years of age. Rexulti was originally approved in 2015 for treating schizophrenia in adults and for adjunctive treatment of major depressive disorder in adults. The sNDA
Devices
Medtronic has recalled its Synergy Cranial and StealthStation S7 Cranial software due to potential inaccuracies caused by the device’s Biopsy Depth Gauge Cycle View. “If the user encounters the software issue where the graphical Biopsy Depth Gauge is no longer synchronized with other navigation views, it may result in
Drugs
CDER approved 50 new drugs either as new molecular entities under NDAs or as new therapeutic biologics under BLAs, according to the Center’s 2021 annual report on drug approvals, “Advancing Health Through Innovation.” The report says the “novel drugs CDER approved in 2021 are collectively notable for their potential
Drugs
The U.S. Federal Circuit Court of Appeals has upheld a lower court decision that found valid a Novartis patent covering a dosing regimen for Gilenya (fingolimod), indicated for treating relapsing forms of multiple sclerosis. The court also affirmed a permanent injunction granted against HEC Pharma until the expiration of
Drugs
n-Lorem Foundation says a recent FDA guidance on the manufacturing processes and stability testing required for antisense oligonucleotides (ASOs) to be administered to nano-rare patients will help the foundation in its efforts to develop ASO treatments. The foundation says the guidance supports the importance of ASO technology as
Drugs
An FDA draft guidance on reporting the amount of listed drugs and biological products under section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act would be “exceedingly burdensome,” Pharmaceutical Research and Manufacturers of America tells the agency in a comment letter. It notes that drug company data
Drugs
The Council for Responsible Nutrition (CRN) says an FDA 11/24/21 answer to the council’s 6/1/21 petition asking that the agency revert to its longstanding policy of allowing manufacturers to market dietary supplements containing NAC (N-acetyl-L-cysteine) was nonresponsive in failing to address the
Devices
A federal grand jury returned 1/5 a superseding indictment charging North Carolina physician Anita Jackson with adulteration of medical devices, paying illegal remunerations, making and using materially false healthcare documents, mail fraud, and conspiracy. She faces a maximum of 20 years in prison and $250,000 in fines. The
Devices
FDA has given 510(k) clearance to the VySpine VySpan posterior cervical thoracic system. The company says the system features various screw and hook options, multiple transition rods, and crosslink versatility.
FDA Policy/General
Federal Register notice: FDA has announced that CDER, CBER, CDRH and Center for Tobacco Products have modified their organizational structures, which were approved by HHS 11/24/2021. To view the notice, click here.
Devices
FDA has cleared a Meridian Bioscience 510(k) for the Curian Campy assay, a rapid, qualitative fluorescent immunoassay for detecting Campylobacter-specific antigen including C. jejuni, C. coli, C. upsaliensis, and C. lari in human fecal specimens. It produces objective results in about 20 minutes on the company’s Curian
FDA Policy/General
A revised Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals took effect 1/1. Attorney Faraz Siddiqui (Hyman, Phelps & McNamara) says many of the code’s changes involve drug manufacturer practices covering speaker events, including meals, choice of venue, and attendance. Writing in his
Drugs
FDA has lifted a clinical hold on a Spero Therapeutics Phase 2 trial of SPR720, an investigational oral product being developed for nontuberculous mycobacterial disease. Spero describes SPR720 as a novel class of antibacterial agents that target enzymes essential for bacterial DNA replication. The hold was placed after FDA reviewed
FDA Policy/General
Faced with safety concerns from the quick spreading omicron coronavirus variant, FDA says it has temporarily postponed all face-to-face domestic and foreign inspectional work except for “mission-critical” inspections. The inspection pause is expected to last until 1/19. FDA notes that while it will continue conducting mission-
Drugs
FDA has released the FDA-483 issued following a 9/13-11/18/21 inspection at Ideal Pharmacy, a Union, NJ, compounding pharmacy. The seven inspection observations were: * ISO-5 classified areas were not certified under dynamic conditions; * media fills were not performed that closely simulate aseptic compounding operations incorporating,
FDA Policy/General
Federal Register notice: FDA has announced that its Office of the Chief Scientist has modified its organizational structure, which was approved by HHS 11/24/2021. To view the notice, click here.
Drugs
The CDER Office of Pharmaceutical Quality (OPQ) has published a Manual of Policies and Procedures (MAPP) describing the policies and procedures for OPQ product quality assessors to ensure consistent assessment of excess volumes in injectable drug products packaged into vials. The MAPP addresses both liquid and solid drug products that