FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide.” The document is intended to help small entities comply with the final rule on the classification of posterior cervical screw systems. It says that while posterior cervical screw systems
Devices
Faced with the problem of allowing about 200 Covid-19 serology (antibody) tests on the market without normal vetting or reviews, FDA 5/4 tightened expectations for antibody test developers to market such tests. Based on a lack of testing at the beginning of the pandemic, the agency had relaxed
Drugs
FDA has approved a Tolmar Pharmaceuticals NDA for Fensolvi (leuprolide acetate) for injectable suspension for treating pediatric patients two years of age and older with central precocious puberty (CPP). The rare disease is defined as the onset of puberty before age eight in girls and before age nine in boys,
Drugs
FDA has accepted for review a KemPharm NDA for its investigational product candidate KP415 (serdexmethylphenidate) for treating attention deficit hyperactivity disorder (ADHD). The company is expecting a user fee review action target of 3/2021. Serdexmethylphenidate is KemPharm’s prodrug of d-methylphenidate (d-MPH) and was designed to address
FDA Policy/General
[Review by Jim Dickinson] The global Covid-19 pandemic has brought accountability to the forefront for both the regulated industry and regulators, law book author Roseann B. Termini tells FDA Webview in a brief statement. “Compliance is critical and Congress has demanded that FDA step up enforcement of possible fraudulent
Drugs
FDA’s moratorium on domestic and foreign inspections during the Covid-19 emergency has been extended indefinitely. In early March, FDA first postponed foreign inspection of regulated products until 5/1. Shortly thereafter, domestic inspections were postponed too. FDA spokesman Jeremy Kahn told FDA Webview 5/4 that the agency
Drugs
Rep. Anna G. Eshoo (D-CA) and Rep. Susan W. Brooks (R-IN) have introduced bipartisan legislation entitled Prescription for American Drug Independence Act. The legislation would require the National Academies of Sciences, Engineering, and Medicine to convene a committee of experts to analyze the U.S.’s dependence on
Drugs
FDA has issued an updated guidance on “Investigational Covid-19 Convalescent Plasma.” The document provides recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from Covid-19. It also provides recommendations to blood establishments on collecting convalescent
FDA Policy/General
DEVICES FDA has approved Roche’s cobas Plasma Separation Card, a sample collection device for HIV plasma viral load testing. Previously, plasma viral load results required blood samples to be cooled during transport to the lab. The new device allows quantitative testing of patients with HIV living in remote areas
FDA Policy/General
Novo Nordisk says its diabetes drug Victoza (liraglutide) injection 1.2 mg or 1.8 mg reduced the risk of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 13% vs placebo in a recent trial involving 9,340 adults. “Victoza is the only approved
Drugs
FDA has granted Gilead Sciences an emergency use authorization for its antiviral drug remdesivir for treating suspected or laboratory-confirmed Covid-19 in adults and children hospitalized with severe disease. “While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (Revised).” The revision describes, among other things, how FDA intends to prioritize its enforcement resources with regard to the marketing of
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species — 21 CFR Part 516” (OMB Control Number 0910-0620). FDA regulations (21 CFR part 516) specify, among other things, the criteria and procedures for requesting eligibility
Devices
FDA has posted a final guidance entitled “Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide.” The document supports requirements published 4/1/2019 in a final rule entitled “Classification of Posterior Cervical Screw Systems.” The guide is intended to help small entities comply with the final rule on
Drugs
FDA has approved a Janssen Biotech BLA for subcutaneous Darzalex Faspro (daratumumab and hyaluronidase-fihj) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. Approval is based on data from the Phase 3 COLUMBA and Phase 2 PLEIADES studies, which showed that the fixed-dose subcutaneous formulation reduced
Drugs
FDA has accepted for review a Bristol Myers Squibb NDA for CC-486, an investigational oral hypomethylating agent for the maintenance treatment of adult patients with acute myeloid leukemia (AML). The drug is intended for patients who achieved complete remission (CR) or CR with incomplete blood count recovery, following induction
FDA Policy/General
After years of stagnation, the vaccines development industry is likely to see a renaissance under pressure from the Covid-19 pandemic, predicts Alliance for a Stronger FDA. In a 5/1 commentary, Alliance deputy executive director Steven Grossman writes that the pandemic will lead to a resurgence in the moribund
Drugs
A task force from BioPhorum and the Pharmaceutical Process Analytical Round Table tells FDA the pharmaceutical and biopharmaceutical industries are facing challenges and uncertainties with regards to regulatory expectations for the validation, registration, and lifecycle management of multi-variate data analysis (MVDA) models used in process analytical technology and real-
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) describing the policies and procedures for collaborative identification, evaluation, and resolution of a newly identified safety signal (NISS) associated with marketed drugs. The MAPP notes that multiple Center offices have roles in identifying, evaluating, and resolving a NISS, depending on
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Information Sharing Among Constituent Part Applicants — 21 CFR 4.103 (OMB Control Number 0910-0834).” The collection request applies to requirements under the Postmarketing Safety Reporting Rule for Combination Product for Constituent Part Applicants to share specified
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the Covid-19 Public Health Emergency.” The document communicates the agency’s intention not to enforce certain requirements for the onsite monitoring activities and
FDA Policy/General
Federal Register notice: FDA has postponed a 6/9-planned Ophthalmic Devices Panel of the Medical Devices Advisory Committee meeting. Panel members were set to review a Refocus Group PMA for the VisAbility Micro Insert, indicated for bilateral scleral implantation to improve unaided near vision in phakic, presbyopic patients between