Devices
Although the revised FDA unified agenda shows that a final rule on laboratory-developed tests may be published in 4/2024, attorney Allyson Mullen (Hyman, Phelps & McNamara) questions whether the agency can be ready by then. Writing in her firm’s FDA Law Blog, Mullen cites the time FDA
Drugs
A new analysis by Friends of Cancer Research (FOCR) finds that more than half of all oncology drugs approved by FDA in the last decade had a postmarketing requirement (PMR) to obtain better dosing (optimal dose) information. “Traditionally, early-phase oncology clinical trials aimed to identify the maximum tolerated dose
Devices
FDA has approved a ReShape Lifesciences PMA supplement for the company’s next-generation Lap-Band 2.0 FLEX, an implant indicated for weight reduction in patients with obesity. “Compared to our current Lap-Band, the Lap-Band 2.0 has a new feature called FLEX Technology, which acts as
Drugs
MAPS Public Benefit Corp. has filed what it calls the first NDA submission for a psychedelic-assisted therapy, MDMA (midomafetamine capsules), for use in combination with psychological intervention for treating post-traumatic stress disorder (PTSD). Psychological intervention includes psychotherapy, talk therapy, or other supportive services provided by a qualified healthcare
Drugs
America First Legal (AFL) has sued FDA and HHS for “illegally concealing government records related to the suppression of hydroxychloroquine (HCQ) and ivermectin to treat Covid-19.” AFL, which is run by controversial former Trump Administration senior advisor Stephen Miller, filed Freedom of Information Act (FOIA) requests last year to
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Peloton Therapeutics Welireg (belzutifan), indicated for treating adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors. The regulatory review period is
Drugs
FDA has accepted for review a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) as a daily treatment for heartburn associated with non-erosive gastroesophageal reflux disease (GERD) in adults. The agency has set a user fee review action target date of 7/19/2024. The submission is based on data from
Drugs
FDA has issued a revised final guidance entitled “Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements.” The document provides recommendations for presenting information that is described as numerically addressing the likelihood or magnitude of a drug’s efficacy or risks. It also outlines
Devices
Former Decision Diagnostics (DECN) CEO Keith Berman (Westlake Village, CA) has pleaded guilty to securities fraud, wire fraud, and obstruction of an official proceeding in connection with his 2020 scheme to defraud investors by falsely telling them FDA clearance was imminent for a blood-based Covid-19 test. According to
Drugs
FDA has notified isotretinoin manufacturers that they must modify their iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) to minimize the burden on patients, pharmacies, and prescribers. According to a letter sent to registered iPLEDGE REMS sponsors, drug manufacturers have six months to make the following changes: * Remove the requirement that
Drugs
FDA has accepted for review an Ascendis Pharma NDA for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism. In May, FDA issued a complete response letter on the original NDA, citing manufacturing control strategy concerns related to the variability of the delivered dose in the drug/device combination product, according
Drugs
Cipla’s InvaGen Pharmaceuticals unit has recalled one lot of vigabatrin for oral solution, USP 500mg, due to seal integrity issues that could allow powder leakage from the pouch. “An improper seal in the pouch may lead to the leakage of powder blend outside the pouch, resulting in a lower
Drugs
People for the Ethical Treatment of Animals (PETA) is urging FDA to move away from animal experiments in its laboratories and to use more non-animal, human-relevant research methods. In a 12/11 letter to FDA commissioner Robert Califf, PETA highlights what it calls numerous “egregious violations of animal
Biologics
FDA has accepted for review a Pfizer BLA for its anti-tissue factor pathway inhibitor (anti-TFPI) candidate marstacimab for treating hemophilia A or hemophilia B without inhibitors to Factor VIII or Factor IX. The agency has set a user fee review action target date in the fourth quarter of
Biologics
FDA has approved the first two cell-based gene therapies for treating sickle cell disease in patients 12 years and older — Vertex Pharmaceuticals’ Casgevy and Bluebird Bio’s Lyfgenia. Casgevy is the first FDA-approved treatment to use the novel genome editing technology CRISPR/Cas9, “signaling an innovative advancement in
Drugs
Novartis says updated Kisqali (ribociclib) data from the Phase 3 NATALEE trial reinforce an earlier benefit seen in an interim analysis — a 25.1% reduction in risk of disease recurrence in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early
Drugs
FDA has issued a guidance entitled “Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.” The document describes FDA’s interpretation of the requirements of the Act and it provides recommendations for robust verification systems for the determination, quarantine and investigation of suspect products, as well
Devices
Getinge has recalled its CardioHelp Emergency Drive due to a possible blocking or impairment of the emergency crank. CardioHelp is intended to help oxygenate blood and remove carbon dioxide from it. “It moves blood through a circuit outside the body to support the heart and lungs for up to six
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of Bayer’s Cipro (ciprofloxacin HCl) oral tablets under NDA #019537 and five related ANDAs that referenced the NDA. The actions are based on the agency’s determination that the products’ effectiveness for treating acute uncomplicated cystitis is not supported by the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Time and Extent Applications (TEA) for Nonprescription Drug Products.” The agency says the Coronavirus Aid, Relief, and Economic Security Act included provisions on the way certain OTC drugs are regulated, such as adding section 505G to the
Devices
Cardinal Health has recalled its Covidien and Cardinal Health brand urology and operating room-specific kits and trays that contain 0.9% sodium chloride irrigation USP and sterile water for irrigation USP supplied by Nurse Assist. The recall is based on last month’s Nurse Assist, LLC recall of the
Drugs
FDA says it does not intend to take regulatory action against an outsourcing facility for compounding a drug product using a bulk drug substance that is not on the Section 503B bulks list if the drug (1) appeared on the agency’s drug shortage list within 60 days of distribution