Drugs
FDA has accepted for review a Merck supplemental BLA for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for preventing invasive pneumococcal disease in children six weeks through 17 years of age. The agency has set a user fee review action target date of 4/1/2022. “Vaxneuvance has the potential to
Drugs
FDA has issued a complete response letter for the BeyondSpring Pharmaceuticals NDA seeking approval of plinabulin in combination with granulocyte colony-stimulating factor to prevent chemotherapy-induced neutropenia (CIN). The company says the agency indicated the NDA cannot be approved at this time because the results of the single registrational
FDA Policy/General
Federal Register notice: FDA is classifying isocapnic ventilation devices into Class 2 (special controls), following a de novo classification request from Thornhill Research for its ClearMate device. The agency has identified it as a prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Financial Disclosure by Clinical Investigators” (OMB Control Number 0910-0396). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the renewal of its Patient Engagement Advisory Committee for an additional two years beyond the charter expiration date. The new charter will be in effect until 10/6/2023. To view the notice, click here.
Drugs
FDA has approved Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with Kyprolis (carfilzomib) and dexamethasone (Kd) to treat adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. The company says the safety profile of Darzalex Faspro plus carfilzomib
Drugs
FDA has released 15 Fiscal Year 2022 GDUFA science and research priority initiatives. The agency says the initiatives are organized according to the categories of complex generic drug products described in the GDUFA 2 commitment letter, followed by a category addressing tools and methodologies for evaluating bioequivalence and therapeutic equivalence
Drugs
FDA has extended by three months its review of a CTI BioPharma NDA for treating adult patients with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis. The new user fee review action target date is 2/28/2022. “In the course of product
Drugs
FDA has lifted its clinical hold on Statera Biopharma’s entolimod research and development activity in acute radiation syndrome. The company says that based on its response to the agency, FDA has acknowledged that Statera satisfactorily addressed historical regulatory matters. The company says that on the basis of data demonstrating
Devices
FDA has added four items to its medical device cybersecurity online post: * the availability of a threat modeling playbook that discusses best practices for understanding basic threat modeling concepts and processes and how to apply them to medical devices; * a joint FDA/University of California San Francisco-Stanford Center of
Devices
FDA says the overall benefits of titanium-based NuInvasive Precice devices outweigh the known risks for on-label use with the updated labeling, compared to alternative treatments. In a 12/1 online notice, the agency says the instructions for use for titanium-based Precice devices have been updated to include
Drugs
FDA has cleared an Immunexpress 510(k) for its SeptiCyte Rapid, a diagnostic aid for use in differentiating sepsis from infection-negative systemic inflammation in hospitalized patients suspected of sepsis. The device contains all the reagents needed for “quantification of gene expression using a reverse transcription polymerase chain reaction (PCR)
Biologics
FDA has issued a clinical hold for undisclosed reasons on an Ocugen IND intended to evaluate the company’s Covid-19 vaccine candidate, BBV152, which is known as Covaxin outside the U.S. The company is awaiting formal written communication from the agency that will outline the deficiencies. Earlier this
Drugs
Stakeholders are contacting FDA to express opposition to or concerns about the agency’s recent reclassification of drug products as drug-led combinations whose components require additional regulatory review. The Association for Accessible Medicines (AAM), representing the generic drug industry, is calling on the agency to rescind its reclassification decision.
Devices
FDA 5/25-6/24 inspections at three Invacare manufacturing facilities identified Quality System Regulation violations in the firm’s manufacturing of a variety of Class 2 oxygen concentrators intended for patients with respiratory disorders requiring supplemental oxygen. An 11/18 Warning Letter says specific violations were: * failing to investigate
Drugs
AdvaMed says it supports FDA efforts to provide up-to-date guidance to help clinical investigators comply with IDE studies. In an 11/19 comment on an agency draft guidance, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices, AdvaMed makes both general and specific comments. It says that while
Drugs
FDA’s Antimicrobial Drugs Advisory Committee 11/30 narrowly voted 13-10 to recommend an emergency use authorization for Merck’s oral antiviral molnupiravir (MOV) for treating Covid-19 patients. An FDA advisory committee briefing document released in advance of the meeting said data show that MOV was associated with
Devices
Three Hyman, Phelps & McNamara attorneys say an 11/15 HHS announcement withdrawing the Trump administration’s policy preventing FDA from requiring premarket review of laboratory-developed tests (LDTs) without notice and comment rulemaking raises many questions. Writing in their firm’s FDA Law Blog, the attorneys say the “announcement
Drugs
FDA has issued Fennec Pharmaceuticals a second complete response letter on its NDA for Pedmark (sodium thiosulfate, intravenous) for preventing ototoxicity (hearing loss) associated with cisplatin chemotherapy in pediatric patients with localized, non-metastatic, solid tumors. The letter again cited “manufacturing deficiencies,” which the company says need to be satisfactorily
FDA Policy/General
Federal Register notice: FDA is requesting nominations for voting members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. Nominations received on or before 1/31/2022 will be given first consideration for membership on the committee. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products. The document provides sponsors with considerations about designing a registry or proposing to use an existing registry to support a regulatory decision about a
Drugs
Amgen says it supports FDA issuance of a draft guidance, Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision Making for Drug and Biological Products, that gives sponsors, researchers, and other stakeholders considerations when proposing to use electronic health records or medical claims data