Drugs
FDA is asking the Oncology Drugs Advisory Committee whether a regulatory decision on Incyte’s retifanlimab to treat advanced or metastatic squamous carcinoma of the anal canal (SCAC) should be delayed until further clinical trial data are available. An agency briefing document released in advance of a 6/24 committee
FDA Policy/General
FDA says its review of a Web site and Amazon storefront maintained by Fresh Nutrition, Inc., Yorba Linda, CA, determined that the company is taking orders for several products that are legally considered to be drugs for use in diagnosing, curing, mitigating, treating, or preventing disease in humans and animals.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Daiichi Sankyo’s Turalio (pexidartinib), indicated for treating adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery. The regulatory review period is
Devices
FDA has released the FDA-483 issued following a 1/13-1/16 inspection at Venus Concept, a San Jose, CA, manufacturer. The two inspection observations were: * failing to adequately document corrective and preventive action activities and/or results; and * failing to adequately maintain complaint files.
Drugs
Just-posted FDA review documents show how CDER management reconciled using the accelerated approval pathway for Biogen’s Alzheimer’s drug Aduhelm (aducanumab) and dismissed reviewers’ recommendations for traditional approval or outright denial of the BLA submission. A memo from CDER Office of New Drugs director Peter Stein noted that
Drugs
A column posted online at The Conversation by a physician and a pharmacist at the University of Connecticut says the likelihood of drug manufacturing errors that slip through the cracks has increased as a result of decreased FDA facility inspections. “Over the past few years, tens of millions of doses
Devices
The HHS Inspector General (IG) says FDA should be working with the Centers for Medicare and Medicaid Services (CMS) on cybersecurity for networked medical devices in hospitals. In an Issue Brief, the IG says that without proper cybersecurity controls, hospitals’ networked medical devices can be compromised, which can lead to
Biologics
The House Oversight Committee and Select Subcommittee on the Coronavirus Crisis have written to top executives of AstraZeneca and Johnson & Johnson as part of an expanded investigation into manufacturing problems at the Emergent BioSolutions Bayview facility that resulted in millions of doses of Covid vaccine being destroyed or quarantined.
Biologics
FDA plans to “move rapidly” to add a Warning to fact sheets for the Pfizer and Moderna Covid-19 vaccines about the rare risk of developing inflammatory heart conditions. Politico reports that CBER vaccine division deputy director Doran Fink told a 6/23 meeting of a Centers for Disease Control
Drugs
Janssen Pharmaceutical has submitted an NDA for Xarelto (rivaroxaban) and its use in pediatric patients. The company says the NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients less than 18 years of age after at least five days
Drugs
Attorney Josephine Torrente (Hyman, Phelps & McNamara) says FDA has drug sponsors at a disadvantage by refusing to hear appeals from an end-of-phase 2 (EOP2) disagreement over Phase 3 study parameters. Writing in her firm’s FDA Law Blog, Torrente says in 2015 the agency revised its 15-
Drugs
FDA says its review of a Web site maintained by Molecular BioLife, Sheldon, IA, determined that the firm takes orders for Shark 2 Collagen and Balanced Kollagen. A just-released 4/15 Warning Letter says the claims on the firm’s Web site establish that the products are drugs because
FDA Policy/General
Former FDA chief counsel Stacy Cline Amin has joined Morrison & Foerster as a partner in its life sciences/healthcare practice. Amin resigned from FDA in January (see story) after almost two and a half years at the helm of the agency’s legal shop. Prior to FDA, she served
Drugs
Agios Pharmaceuticals has submitted an NDA for mitapivat for treating adults with pyruvate kinase (PK) deficiency. The company says there are no approved therapies for PK deficiency, and current treatments include blood transfusions and splenectomy, which are associated with both short- and long-term risks, including iron overload, blood clots
Drugs
Researchers in pharmaceutical and academic settings say FDA regulatory guidance should be updated to acknowledge the utility of external controls in drug trials, particularly retrospective natural history data. Writing in an open-access article in Therapeutic Innovation and Regulatory Science, the authors discuss their review of 45 FDA approvals between
FDA Policy/General
Federal Register notice: FDA has announced for administrative purposes the issuance of an emergency use authorization to B. Braun Melsungen AG and the use of its sedative propofol-lipuro 1% injectable emulsion in Covid-19 patients requiring mechanical ventilation. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Alnylam Pharmaceuticals’ Givlaari (givosiran), indicated for treating adults with acute hepatic porphyria. The regulatory review period is 1,533 days, which includes 1,363 days that occurred during the testing phase and 170 days during
Drugs
Merck has reported favorable data from a study investigating its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with platinum-based chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin), with or without bevacizumab, for first-line treatment of patients with persistent, recurrent or metastatic cervical cancer. The company says the
Devices
At the 4/7 MDUFA 5 reauthorization meeting, FDA presented its initial proposal for a total product lifecycle (TPLC) advisory program (TAP). According to meeting minutes, the agency said the current MDUFA program has been optimizing a limited portion of the TPLC. “By investing in earlier and more strategic coordination
Drugs
FDA has issued a guidance, Providing Regulatory Submissions in Electronic Format—Standardized Study Data, with the requirements for electronic submission of standardized clinical and non-clinical study data under Section 745 (a) of the Federal Food, Drug, and Cosmetic Act. The document implements the electronic submission requirements for study data
Drugs
FDA has accepted for filing Fennec Pharmaceuticals’ resubmission of an NDA for Pedmark, described as a unique formulation of sodium thiosulfate for preventing ototoxicity induced by cisplatin chemotherapy in patients one month to less than 18 years of age with localized, non-metastatic solid tumors. The company says the PDUFA
Devices
FDA has cleared a CoreLink 510(k) for the F3D Corpectomy VBR System, a vertebral body replacement that is intended to surgically replace one or more damaged vertebral bodies in the cervical and thoracolumbar spine. The implant is designed to provide support while fusion occurs, the company says. The system