Drugs
FDA says a Web site maintained by NeuroHydrate, Bridgeport, CT, is selling HM-Formula, which is legally considered to be an unapproved new drug intended for use in the cure, mitigation, treatment, or prevention of disease. A just-released 4/27 Warning Letter cites many of the claims made for
Devices
FDA says it has posted the ninth spreadsheet of reportable adverse events submitted by Bayer for its withdrawn Essure birth control device. The latest spreadsheet covers February of this year, FDA says (contains link to all spreadsheets). The notice also says Bayer posted its third quarterly analysis report of adverse
Drugs
FDA has lifted a clinical hold on Regeneron and its odronextamab monotherapy trials in patients with follicular lymphoma and diffuse large B-cell lymphoma. Trial protocols have been amended to further reduce the incidence of Grade 3 or greater cytokine release syndrome during step-up dosing, the company says, adding
Drugs
FDA says it is implementing an interim process to communicate issues identified following a review of records or other information requested in lieu or in advance of a pre-approval or pre-license inspection for CDER regulated products. An agency online notice, Manufacturing, Supply Chain, and Drug Inspections, says FDA
FDA Policy/General
As the U.S. continues to recover from the Covid-19 health emergency, FDA acting commissioner Janet Woodcock says the agency is at a critical inflection point and will begin to “more closely examine our response to this crisis, gauge what does work and formulate and implement plans to effectively
FDA Policy/General
Federal Register notice: FDA has determined that Adams Technologies’ Isoptin (verapamil hydrochloride) tablets (40mg, (XXX INSEDRT SPACE AFTER COMMA XXX)80mg and 120mg) and Pfizer’s Calan (verapamil hydrochloride) tablets (40mg, 80mg, 120mg and 160mg) were not withdrawn due to safety or effectiveness reasons. The determinations permit FDA to approve
Drugs
FDA acting commissioner Janet Woodcock says the Covid-19 pandemic has revealed issues with the clinical trial system in the U.S. that need to be addressed. In an interview with Outsourcing Pharma, she says there are gaps in the clinical trial infrastructure that could be overcome by creating a
Drugs
FDA says Bio-Botanica/Nature’s Answer’s Coral Calcium, that contains cesium chloride as a dietary ingredient and is labeled as a dietary supplement, is adulterated because cesium chloride is a new dietary ingredient. A 5/5 Warning Letter says there is no information demonstrating that cesium chloride was
Drugs
Four cancer researchers say that while the Covid-19 pandemic affected all clinical trials in the early waves of the disease, the impact on oncology trials was less severe compared with non-oncology trials. “As vaccines continue to be rolled out,” they write in an online Nature article, “we expect
Drugs
FDA has issued a final guidance entitled COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention Guidance for Industry. The document provides recommendations on master protocols evaluating drugs for treating or preventing Covid-19. An agency notice defines a master protocol as a “protocol designed with
FDA Policy/General
The Medical Device Innovation Consortium (MDIC), of which FDA is a member, has announced a partnership with Booz Allen Hamilton to establish a benchmark of the medical device industry’s cybersecurity maturity and create resources to measure maturity over time. The benchmark will help the industry to improve product security
Drugs
FDA has posted a revised guidance entitled Manufacturing, Supply Chain, and Drug and Biological Product Inspections During Covid-19 Public Health Emergency — Questions and Answers. The revision answers questions about regulatory and policy issues related to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products. The
Drugs
FDA says it wants to improve its interactions among external stakeholders and experts, and its own scientists to advance regulatory science. Writing in an online post, FDA chief scientist and Denise Hinton and Office of Regulatory Science and Innovation (ORSI) director Tina Morrison update stakeholders on its Advancing Regulatory Science:
FDA Policy/General
Former FDA deputy commissioner for policy, legislation, and international affairs Anna Abram has joined Akin Gump as a senior advisor in its public law and policy practice. After almost four years at FDA, Abram left her role as FDA’s top policy official in January. While at FDA, Abram led
Drugs
FDA has taken the rare step of publicly correcting misinformation being disseminated by a drug company about an investigational therapy. In a 5/17 notice, FDA says two CytoDyn trials evaluating leronlimab do not support the drug’s clinical benefit in treating Covid-19 despite public company statements suggesting otherwise.
FDA Policy/General
Comments Sought Peptide Clin/Pharm Evaluations 5/14/2021 Federal Register notice: FDA has opened a public docket for comments on “Evaluating the Clinical Pharmacology of Peptides.” The agency is seeking comments on the characterization of the effects of hepatic impairment, drug-drug interactions, and immunogenicity on the pharmacokinetics of
FDA Policy/General
Federal Register notice: FDA has opened a public docket for comments on “Evaluating the Clinical Pharmacology of Peptides.” The agency is seeking comments on the characterization of the effects of hepatic impairment, drug-drug interactions, and immunogenicity on the pharmacokinetics of peptides as well as the effects of peptides on
FDA Policy/General
Federal Register notice: FDA has determined that Taro Pharmaceutical Industries’ Ovide (malathion) lotion, 0.5%, was not withdrawn due to safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements. Ovide is
FDA Policy/General
Federal Register notice: FDA has issued an order debarring Rick Shepard for five years from importing or offering for import any drug into the U.S. Shepard was convicted 9/2020 of one felony count under federal law for conspiracy to import and introduce misbranded drugs into interstate commerce. As
FDA Policy/General
Federal Register notice: FDA has announced a 6/3-4 meeting of the Medical Devices Advisory Committee’s Neurological Devices Panel. On 6/3, the panel will discuss and make recommendations on the classification of topical refrigerants (vapocoolants), which are currently unclassified preamendment devices, to Class 2 (general and special
Devices
CDRH expects to release by the end of the year an updated draft guidance on medical device cybersecurity premarket submission recommendations. Speaking at a 5/13 FDA/Xavier MedCon conference, CDRH cybersecurity policy analyst Matthew Hazelett said the 2018-released draft on Content of Premarket Submissions for Management of Cybersecurity
FDA Policy/General
Federal Register notice: FDA has announced a 6/24 Oncologic Drugs Advisory Committee that will discuss an Incyte BLA for retifanlimab injection. The proposed indication is for treating adult patients with locally advanced or metastatic squamous carcinoma of the anal canal who have progressed on from or who are intolerant