Drugs
Writing online for Drug & Device Law, attorneys Dick Dean and Emmanuel Sanders (Tucker Ellis) speculate whether recent changes in personnel on the Supreme Court could bring an end to Wyeth v. Levine, the case that held that a jury can second-guess whether an FDA-approved label is adequate.
Drugs
FDA has approved an Athenex NDA for Klisyri (tirbanibulin) for the topical treatment of actinic keratosis on the face or scalp. Approval is based on data from two pivotal, randomized, double-blind, vehicle-controlled Phase 3 studies (KX01-AK-003 and KX01-AK-004) that evaluated tirbanibulin ointment 1% in
Devices
FDA has granted Spark Biomedical a Breakthrough Device Designation for the Roo System: a transcutaneous electrical nerve stimulator that aids in reducing signs and symptoms of neonatal opioid withdrawal syndrome, which results from exposure to prescription or non-prescription opioids or heroin during pregnancy. The device is based on the
Biologics
Some 20 U.S. Senate Democrats are asking the leaders of Operation Warp Speed to respond to questions about reports that the federal government declined to exercise its option to purchase additional doses of the Pfizer Covid-19 vaccine earlier this year. “We are concerned the failure to secure an
Drugs
Mesoblast says the DREAM-HF Phase 3 trial of its allogenic cell therapy rexlemestrocel-L (Revascor) in 537 patients with advanced chronic heart failure demonstrated a 60% reduction in the incidence of heart attacks or strokes and 60% reduction in death from cardiac causes when treated at an earlier stage
Drugs
The American Civil Liberties Union (ACLU) is criticizing a second Trump administration Supreme Court petition to uphold an FDA requirement that patients seeking an early abortion pill go to a health center to sign a form and obtain the drug, even during the Covid-19 pandemic. The ACLU says the
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. JC Ayur Life, Yorba Linda, CA (10/29): FDA recently reviewed the company’s Web site and Facebook page and determined that it takes orders for its product “Heritage
Devices
FDA has approved a Foldax IDE to begin a clinical study of its Tria biopolymer mitral surgical heart valve. The device is made out of a new, proprietary biopolymer – LifePolymer – and is intended to resist calcification, withstand stresses and strains without failure, and restore patient quality of life without lifelong
Drugs
FDA has granted Gannex a fast track designation for its non-alcoholic steatohepatitis (NASH) drug candidate ASC42, which the company describes as a novel non-steroidal, selective, potent Farnesoid X Receptor agonist. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation and fibrosis, Gannex says. It
Drugs
FDA has approved a shorter two-hour infusion time for Genentech’s Ocrevus (ocrelizumab) — dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs). The dosing approval was based on data from the randomized, double-blind
Devices
A just-filed citizen petition is requesting that FDA not treat “daily-wear uniform scrubs” as medical devices. The petition, which was filed by the law firm Loeb & Loeb on behalf of an unnamed garment maker, is asking for enforcement discretion for the scrubs that are “intended for every
Drugs
A new FDA Web site posting discusses the agency’s surrogate endpoint (SE) table that was mandated by the 21st Century Cures Act of 2016. The table is intended to increase transparency by informing stakeholders about the development of novel SEs. “It also provides consistency in the application of existing
FDA Policy/General
Federal Register notice. FDA has made available three device-specific final guidance documents for the Safety and Performance Based Pathway: Spinal Plating Systems — Performance Criteria for Safety and Performance Based Pathway; Orthopedic Non-Spinal Metallic Bone Screws and Washers — Performance Criteria for Safety and Performance Based Pathway; and Magnetic Resonance
FDA Policy/General
FDA has approved Revivicor’s intentional genomic alteration (IGA) in GalSafe pigs for use as food and human therapeutics. “This is the first IGA in an animal that the FDA has approved for both human food consumption and as a source for potential therapeutic uses,” an FDA release says The
FDA Policy/General
Notice Corrected on Drug Development Tools Guide Federal Register notice: FDA is correcting an 11/25 notice entitled Qualification Process for Drug Development Tools; Guidance for Industry. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section, and this notice corrects the error. To view
Devices
FDA has granted ReCor Medical a breakthrough device designation for Paradise Ultrasound Renal Denervation System and its use for treating patients with uncontrolled hypertension who are inadequately responsive to anti-hypertensive medications. The designation is based on recent positive data from the RADIANCE-HTN TRIO study, according to the company.
Devices
FDA has posted three new guidances for device makers to use under its Safety and Performance-Based Pathway. Manufacturers have the option to use FDA-identified performance criteria to demonstrate that a device is as safe and effective as its predicate. The guidance Spinal Plating Systems – Performance Criteria for Safety
FDA Policy/General
Federal Register notice: FDA is correcting an 11/25 notice entitled Qualification Process for Drug Development Tools; Guidance for Industry. The document was published with incorrect information in the Paperwork Reduction Act of 1995 section, and this notice corrects the error. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 10 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed. The applicants also waived their opportunity for a hearing. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has extended the comment period on a draft guidance entitled Electromagnetic Compatibility of Medical Devices. Electronic or written comments can be submitted until 2/16/2021. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Bone, Reproductive and Urologic Drugs Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 3/23/2022. To view the notice, click here.
Drugs
FDA has granted Lexicon Pharmaceuticals a fast track designation for LX9211 and its use in treating diabetic peripheral neuropathic pain. The company says it is currently enrolling patients with this condition in a Phase 2 proof-of-concept study and it is preparing to initiate a second Phase 2 clinical