Drugs
FDA has made available a final guidance on enforcing Drug Supply Chain Security Act (DSCSA) requirements for wholesale distributor verification of saleable returned products and dispenser verification of the product identifier for suspect and illegitimate products. The guidance, Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification
FDA Policy/General
Federal Register notice: FDA has announced that it intends to conduct a fit-for-use pilot program to test the processing and analysis of nonclinical study data provided electronically for the Clinical Data Interchange Standards Consortium for Standard for Exchange of Nonclinical Data Implementation Guide: Developmental and Reproductive Toxicology v1.
Devices
FDA has approved Avioq’s VioOne HIV Profile Supplemental Assay, an enzyme-linked immunosorbent assay for confirmation and differentiation of individual antibodies directed to various gene products of HIV-1 (Group M & Group O) and HIV-2 in human serum or plasma. The company says the assay is intended
Drugs
FDA has approved a Gilead Sciences NDA for Veklury (remdesivir), indicated for treating patients with Covid-19 that requires hospitalization. Remdesivir is the first treatment approved for treating Covid-19, according to the agency, and it previously was available in the U.S. under an emergency use authorization for treating
Devices
FDA has granted Cala Health a breakthrough device designation for its Cala Trio targeted therapy for treating action tremors in the hands of adults with Parkinson’s disease. Cala Trio is currently FDA-cleared to relieve hand tremors from essential tremor. The company expects to begin clinical trials evaluating the
Drugs
FDA has approved a Leo Pharma supplemental NDA for updated prescribing information for Enstilar (calcipotriene and betamethasone dipropionate) Foam to include data on long-term use in adults with plaque psoriasis. The corticosteroid is approved for the topical treatment of plaque psoriasis in patients 12 years and older. The submission
Drugs
FDA has posted its latest quarterly report (April-June) of potential signals of serious risks/new safety information identified by the FDA Adverse Event Reporting System. The report lists 24 signals. FDA says it has determined that no action is necessary for four of the signals, while it continues to
Drugs
University researchers in the U.S. and Turkey say that, on average, three additional months of FDA regulatory review delay result in one fewer drug in development in that drug category. Writing in Health Economics the researchers say, “Our results suggest that the length of the regulatory review delay matters
FDA Policy/General
Federal Register notice: FDA has determined that 28 drug products listed in the notice were not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to continue to approve ANDAs that reference the products if they meet legal and regulatory requirements. To view the notice, click
Drugs
FDA has issued a complete response letter in connection with Zosano Pharma’s 505(b)(2) NDA for its Qtrypta (zolmitriptan transdermal microneedle system). The letter reportedly cites inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies. The company says the agency recommended that Zosano conduct a repeat bioequivalence study
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989. The reporting forms are intended to facilitate submissions by drug and biological product application holders of complete and accurate information
Drugs
Eli Lilly says it has retained an outside consultant to “conduct a comprehensive independent review of systems” at its Branchburg, NJ site, following two inspections over the past year that have cited significant GMP concerns. The facility has been designated as one of several that will manufacture the company’s
Drugs
FDA has granted a fast track designation for TG Therapeutics’ combination of its ublituximab, an investigational glycoengineered anti-CD20 monoclonal antibody, and its umbralisib, an investigational once-daily, oral, dual inhibitor of P13K-delta and CK1-epsilon, for treating adults with chronic lymphocytic leukemia. The company says its fast track
Drugs
From 2007 to 2016, Quincy Bioscience’s Prevagen posted dramatic sales increases, even as FDA regulators were raising many questions about the product and the company’s manufacturing processes and even as adverse event reports mounted. A Wired investigative report says three million people are estimated to have bought Prevagen
Devices
FDA has cleared a Tyber Medical 501(k) for its new line of foot and ankle plating systems. The clearance covers over 42 different indication-specific anatomical plating types, the company says, which are indicated to treat a range of deformity, trauma, and degenerative conditions to the forefoot, midfoot, rearfoot,
Devices
FDA has asked Helius Medical Technologies for more information to support its request for de novo classification and clearance of the Portable Neuromodulation Stimulator device as a potential treatment for gait deficit due to symptoms of multiple sclerosis, intended to be used as an adjunct to a supervised therapeutic exercise
Drugs
The Department of Justice says it has reached a global resolution of its criminal and civil investigations into the opioid manufacturer Purdue Pharma and a civil resolution of its civil investigation into individual company shareholders from the Sackler family. The agreements are subject to the approval of the federal bankruptcy
Biologics
FDA is expected soon to remove a clinical hold on AstraZeneca’s Covid-19 vaccine trial after it completed its review of a serious illness in a study participant, according to a report from Reuters. The hold was imposed in September after the University of Oxford, AstraZeneca’s partner in
Drugs
A 2/20-3/5 FDA inspection at RLC Labs, Phoenix, AZ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/9 Warning Letter says the company also failed to fulfill its registration and listing obligations under the Federal Food, Drug, and Cosmetic Act.
Biologics
Merck has announced positive findings from two Phase 3 studies evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine. Data from the PNEU-PATH (V114-016) and PNEU-DAY (V114-017) studies showed favorable immune responses. “Results from both studies are based
Drugs
The Office of Management and Budget (OMB) has given federal agencies until 11/26 to issue final rules needed to implement a 5/19 executive order setting forth 10 principles of fairness that agencies are to consider in administrative enforcement and adjudication actions. The order was issued to help promote
FDA Policy/General
Federal Register notice: FDA has issued an order debarring Keith Komar for five years from importing or offering for import any drug into the U.S. The order is based on Komar’s 2019 conviction for mail fraud for knowingly causing the U.S. mail to deliver from Mumbai, India,