Devices
FDA has granted HistoSonics a breakthrough device designation for its novel sonic (acoustic energy) beam therapy histotripsy and its use to mechanically destroy and liquefy tissue in the liver without incisions, ionizing radiation or heat. The designation was made based on early clinical and pre-clinical results suggesting that histotripsy
FDA Policy/General
Drug Distribution Security Public Meeting 10/14/2021 Federal Register notice: FDA has announced an 11/16 virtual public meeting entitled “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA).” The meeting is intended to provide stakeholders an opportunity to discuss enhanced drug
FDA Policy/General
BIOLOGICS FDA has approved a CSL Behring BLA for Afstyla [antihemophilic factor (recombinant), single chain], a factor VIII single-chain therapy for adults and children with hemophilia A. The company says it is the first and only single-chain product for hemophilia A that is specifically designed for long-lasting
FDA Policy/General
Luminex Corp. and Nanosphere have entered into a definitive agreement under which Luminex will acquire Nanosphere for $1.35 per share in an all cash transaction valued at about $58 million. Nanosphere says it will deliver proprietary diagnostic tools for detecting respiratory, gastroenteric and bloodstream infections. Allergan and Gedeon Richter
Drugs
Lupin Pharmaceuticals has recalled all irbesartan and irbesartan/hydrochlorothiazide tablets after an analysis revealed that certain active pharmaceutical ingredient batches were above the specification limit for the impurity N-nitrosoirbesartan. Irbesartan is an angiotensin II receptor blocker indicated for treating hypertension, and diabetic nephropathy in hypertensive patients with Type 2
Biologics
FDA’s Vaccine and Related Biological Products Advisory Committee 10/15 unanimously (19-0) voted to recommend Johnson & Johnson’s Covid-19 booster vaccine in all adults two months after receiving their initial J&J dose. To date, about 15 million people have received their first J&
Biologics
FDA is reportedly delaying its decision on expanding a Moderna emergency use authorization for its Covid-19 vaccine in adolescents while it further investigates myocarditis risks. According to several news reports, the agency has been assessing the risk among younger men vaccinated with the Moderna vaccine after several Nordic countries
FDA Policy/General
FDA needs a deputy commissioner for regulatory competitiveness to “aggressively develop, coordinate, and drive agency initiatives that allow new medical products and technologies to come to market faster and less expensively — without sacrificing sound regulatory science.” So argues former FDA associate commissioner for external relations and now Center for Medicine
Devices
FDA has provided an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria (NTM) infections in patients who have undergone cardiothoracic surgery using the devices. Two heater-cooler manufacturers (CardioQuip and Gentherm Medical) announced voluntary recalls to provide updated labeling with interim mitigation strategies
Drugs
FDA has approved Genentech’s Tecentriq (atezolizumab) as an add-on treatment following surgery and platinum-based chemotherapy for adults with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1 greater than or equal to 1%. Approval is based on data from an interim analysis
Devices
FDA has decided to regulate novel robot assisted surgery (RAS) devices for specific indications rather than the previous tool-type indication they were cleared under in the past. Writing in a new FDALawBlog post, Hyman, Phelps & McNamara attorneys Jeffrey K. Shapiro and Allyson B. Mullen take FDA to task
Devices
CDRH director Jeffrey Shuren and Office of Product Evaluation and Quality director William Maisel say the Center’s Digital Transformation Initiative is strengthening the premarket review program. Writing in an online FDA Voices post, Shuren and Maisel say that building a robust infrastructure within FDA and efficient external data interfaces
Devices
FDA has denied three 2017 and 2018 petitions submitted by Chul-Hi Park, Ph.D., Seoul, Korea, asking the agency to prevent clearance for marketing any specific devices without proof of safety and effectiveness and retroactively regulating formerly cleared specific devices to provide similar data on safety and effectiveness. The
Drugs
Teligent Pharma has recalled five lots of lidocaine HCl Topical Solution 4%, 50ml in screw cap glass bottles because the firm’s testing has found it to be super potent based on an out-of-specification result obtained at its 18-month stability timepoint. “An increased lidocaine dose could lead
Drugs
FDA has accepted for priority review a Regeneron Pharmaceuticals BLA for Regen-Cov (casirivimab and imdevimab) for treating Covid-19 in non-hospitalized patients and as prophylaxis in certain individuals. Currently, the therapy is authorized under an emergency use authorization to treat people with mild to moderate Covid-19 who
FDA Policy/General
Federal Register notice: FDA has announced an 11/16 virtual public meeting entitled “Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act (DSCSA).” The meeting is intended to provide stakeholders an opportunity to discuss enhanced drug distribution security requirements of the DSCSA related to
Devices
Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) are calling on FDA to quickly issue new regulations for over-the-counter hearing aids. In a 10/12 letter, they say their 2017 Over-the-Counter Hearing Aid Act “removes outdated regulations blocking consumer access to affordable hearing aids
Drugs
CDER’s Office of Compliance has been targeting three enforcement areas in drug advertising and promotion — fraudulent Covid-19 products, products containing hidden drug ingredients, and illegally marketed opioid products. Speaking at an enforcement update at the Food and Drug Law Institute’s annual advertising and promotion conference 10/13,
Drugs
FDA’s Vaccines and Related Biological Products Advisory Committee 10/14 voted unanimously to support Moderna’s request for an emergency use authorization (EUA) for a booster dose of its mRNA Covid-19 vaccine. Panel members agreed that the booster dose was appropriate for older and higher-risk adults who
FDA Policy/General
Three sources have told the Washington Post that the White House is close to naming former FDA commissioner Robert Califf to the position again. The Post says that under federal law Biden faces a mid-November deadline to either nominate acting commissioner Janet Woodcock or name someone else to the
Devices
FDA says the 9/2 Abbott Molecular recall of its Alinity m SARS-Cov-2 AMP kit and Alinity m Resp-4-Plex AMP kit is Class 1. An agency notice says 187 software installations are being corrected to automate testing with the 9,964,224 distributed tests for Alinity
Devices
FDA says it agrees with priority recommendations made by Booz Allen Hamilton in an independent assessment of the CDRH Covid-19 response in terms of emergency use authorization (EUA) of Covid-19 tests. For its work, Booz Allen Hamilton reviewed primary documents and conducted internal and external stakeholder interviews to