Drugs
Attorney Mark Schwartz (Hyman, Phelps & McNamara) says that with the planned FDA resumption of domestic inspections, there are three likely scenarios involving the still-paused foreign inspections. Writing in his firm’s FDA Law Blog, Schwartz says that either on-site foreign inspections will resume, FDA will loosen an
Drugs
FDA has accepted for priority review a Merck NDA for vericiguat, an oral soluble guanylate cyclase stimulator indicated to reduce the risk of cardiovascular death and heart failure hospitalization following a worsening heart failure event in patients with symptomatic chronic heart failure with reduced ejection fraction, in combination with other
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs.” The document describes FDA’s current thinking on incorporating data from foreign countries into proposed clinical investigational protocols and applications for new animal drugs. To
Devices
A 7/7 CDRH Webinar covered decontamination systems for respirators, including specific methods for decontamination, evidence of potential effectiveness, and best practices and common challenges in emergency use authorization request submissions. The Webinar focused on N95 respirators, the disposable facepiece filtering respirators that cover a user’s airways or nose
Drugs
Four Hogan Lovells attorneys say the Department of Justice (DoJ) is now arguing to the Supreme Court that none of the provisions of the Patient Protection and Affordable Care Act may be severed from the unconstitutional provisions of the act. If the court agrees, they write in an online post,
Drugs
FDA’s Cardiovascular and Renal Drugs Advisory Committee provides a mixed vote (8 to 7) in favor of approval for Mallinckrodt’s terlipressin and its use to treat adults with hepatorenal syndrome (HRS) Type 1. The acute and life-threatening syndrome involves acute kidney failure in people with cirrhosis. A
Drugs
FDA has cleared a Clinical Computer Systems 510(k) for the Obix BeCA fetal monitor. The monitor features the company’s “Locate and Track” technology that detects and maintains contact with the fetal heartbeat. It also has high sensitivity ultrasound transducers that supports fetal monitoring in antenatal and difficult labor
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species.” The document outlines basic statutory and regulatory requirements and special considerations for such drug approvals, and describes the incentives
Drugs
FDA has notified Tricida that the agency has identified deficiencies in the NDA for its drug candidate veverimer that is designed to treat metabolic acidosis in patients with chronic kidney disease. The company says it was told the deficiencies preclude discussion of labeling and postmarketing requirements at this time. Tricida
Devices
FDA says that as part of a CME America 4/27 recall of BodyGuard infusion system administration sets used with the company’s BodyGuard infusion pumps, the company conducted additional flow-rate accuracy testing. “The testing revealed that some infusion sets do not meet the ± 5% delivery accuracy for the
Drugs
FDA says it has approved changes to the labeling for Gilead’s Epclusa (sofosbuvir and velpatasvir) to provide for its use in treating chronic HCV infection in treatment-naïve and treatment-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis. An agency notice summarizes the specific changes to the
Drugs
Four authors from law and medical schools are questioning the FDA reliance on objective evidence in approving medical products, arguing that it is difficult to obtain such evidence in treatments for brain injuries. The Stanford Technology Law Review article says the current agency regulatory approval process for new drugs and
Devices
FDA says that Endologix has issued a correction notice for its Ovation iX system that identifies the root cause of polymer leaks. FDA has classified the action as a Class 1 recall. An agency notice says that no physical removal of the product is planned or needed. The agency says
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Biomarkers and Surrogate Endpoints in Clinical Studies Support Effectiveness of New Animal Drugs.” The document describes FDA’s current thinking on incorporating biomarkers and surrogate endpoints into proposed clinical investigation protocols and applications for new animal drugs. To view
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs.” The document describes FDA’s current thinking on incorporating complex adaptive and other novel investigation designs into proposed clinical investigation protocols and applications for new animal drugs.
Devices
FDA has approved an Edwards Lifesciences PMA for the Konect Resilia aortic valved conduit, a ready-to-implant device for bio-Bentall procedures, a complex surgery that involves replacement of a patient’s aortic valve, aortic root and the ascending aorta. The device features the company’s Resilia tissue, which
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Clinical Investigations for Prostate Tissue Ablation Devices.” The document provides recommendations for clinical investigations for high intensity ultrasound systems for prostate tissue ablation and new types of prostatic tissue ablation devices. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act.” The document, which was mandated by the FDA Reauthorization Act of 2017, requires that certain pre-submissions
Drugs
A Pennsylvania federal judge says that Teva will be the focus of the first trial over an alleged “overarching” industry-wide conspiracy to fix generic drug prices. Three other bellwether trials involving schemes to fix prices on three specific drugs will proceed on separate tracks, the judge said. Bloomberg Law
Drugs
FDA has approved a Janssen Pharmaceutical Companies supplemental BLA for tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA). The drug was approved in 2017 for treating adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Janssen says Tremfya is the first treatment
Drugs
FDA says that commissioner Stephen Hahn will be the keynote speaker at a 7/21 virtual public meeting seeking input on reauthorization of the Generic Drug User Fee Amendments of 2017 for FY 2023-2027 (GDUFA 3). The current GDUFA 2 authorization expires at the end of FY 2022 (9/
Devices
FDA has published a guidance, Providing Regulatory Submissions for Medical Devices in Electronic Format—Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act, to satisfy requirements in the law and the MDUFA 4 commitment letter to provide final guidance documents. “The agency has concluded that it