FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed information collection entitled “Study of Disclosures to Health Care Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug.” The purpose of the research is to examine healthcare providers’ perceptions and behavioral intentions about an unapproved
Drugs
A 6/18-7/2/19 FDA inspection at Washington Homeopathic Products, Berkeley Springs, WV, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other issues. A just-released 6/19 Warning Letter says the specific CGMP violations were: * failing to establish an adequate quality
Drugs
Biogen and Eisai say that Biogen has completed the submission of a BLA to FDA for approval of aducanumab, an investigational treatment for Alzheimer’s disease. A company statement says the completed submission followed ongoing collaboration with the agency and includes data from the Phase 3 EMERGE and ENGAGE studies
Drugs
FDA says its review of a Web site operated by Ionogen, Knoxville, TN, found that the company is marketing its Ionopure Skin & Hands for sale in the U.S. to mitigate, prevent, treat, diagnose, or cure Covid-19 in people. A 7/7 Warning Letter says the agency considers
Devices
FDA says that interim results of a post-marketing surveillance study of Bayer’s withdrawn Essure permanently implanted birth control device show that Essure patients tend to have higher rates of chronic lower abdominal or pelvic pain and abnormal uterine bleeding compared to women who had laparoscopic tubal ligation as
Drugs
Mylan has recalled one lot of daptomycin for injection, 500 mg/vial, due to particulate matter found in one single-dose vial. To date, Mylan has not received any adverse event reports related to the recall, according to a recall notice. The antibacterial is indicated for treating complicated skin and
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed information collection entitled “Study of Multiple Indications in Direct-to-Consumer Television Advertisements.” The study is intended to provide preliminary information on whether consumers face challenges when multiple indications are promoted in a single television ad. It will also explore
Drugs
FDA has issued Merck and Eisai a complete response letter on their request for accelerated approval of an NDA for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). The agency told the companies that another combination therapy (presumably Roche’s Avastin
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a proposed information collection entitled “Healthcare Provider Perception of Boxed Warning Information Survey.” The collection is intended to investigate healthcare providers’ awareness, perceptions, and beliefs about the benefits and risks of an FDA-approved product that carries a boxed warning. It proposes
Drugs
The Microbiome Therapeutics Innovation Group is asking FDA to finalize a 2016 draft guidance that updated a 2013 guidance outlining an enforcement discretion policy on the IND requirements for using fecal microbiota transplantation (FMT) to treat C. difficile infection not responding to standard therapies while the agency further considered the
Drugs
Drug companies have made more than 800 price increases this year and adjusted the cost of 42 medicines up by an average of 3.3% so far this month, according to GoodRx as reported online by Politico. “While the size of that increase is not out of line with past
FDA Policy/General
Federal Register notice: FDA has determined that Mylan’s Zovirax (acyclovir) oral capsule, 200 mg, was not withdrawn from sale for reasons of safety or effectiveness. The determination allows the agency to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory
Drugs
FDA is asking public stakeholders such as patient and consumer advocacy groups, healthcare professionals, and scientific and academic experts to notify the agency if they intend to participate in periodic consultation meetings on PDUFA reauthorization. A Federal Register notice says PDUFA authorization expires 9/2022 and new legislation will be
Drugs
FDA has approved Astex Pharmaceuticals’ Inqovi (decitabine and cedazuridine) tablets to treat adults with myelodysplastic syndromes and chronic myelomonocytic leukemia. An agency statement says the approval “represents an important advance in treatment options for patients with MDS, a type of blood cancer, who previously needed to visit a healthcare facility
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Radioactive Drug Research Committees — 21 CFR 361.1” (OMB Control Number 0910-0053). The collection supports regulations on radioactive drug research committees and their role in approving and monitoring basic research studies using radiopharmaceuticals. To view the
Devices
A 2/10-2/14 FDA inspection at Luminex Corp., Austin, TX, found Quality System Regulation and Medical Device Reporting violations in the firm’s work as a manufacturer of microsphere-based and PCR-based multiplexing systems for in-vitro diagnostic use or life science research use, including software and
Drugs
An 11/25-11/28/19 FDA inspection at Vega Life Sciences, Sangreddy District, Telangana, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). A 6/17 Warning Letter says the specific deviations were: * failing to control and monitor solvent recovery procedures to ensure
Devices
Arrow International has recalled (Class 1) its Arrow AutoCAT 2 Intra-Aortic Balloon Pump and AC3 Optimus Intra-Aortic Balloon Pump Series because both devices have a part called the MForce motor driver that may break, char, and discolor the motor connector wires. The wire wear or breakage may lead
Drugs
Public Citizen has written to HHS secretary Alex Azar, FDA commissioner Stephen Hahn, National Institutes of Health director Francis Collins, and National Institute of Allergy and Infectious Disease director Anthony Fauci asking HHS to announce that FDA will not permit and NIH will not support any clinical trial in which
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of Teva’s NDA for Zecuity (sumatriptan iontophoretic transdermal system) after the company requested its withdrawal. The drug was approved in 2013 for treating migraines, but in 2016 Teva suspended sales, marketing and distribution to investigate the cause of burns and scars associated
Biologics
FDA has placed a clinical hold on a Cellectis multiple myeloma trial (MELANI-01 study) after a study patient died. MELANI-01 is a Phase 1 dose escalation clinical study evaluating a gene-edited T-cell product candidate (UCARTCS1A) for treating patients with relapsed or refractory multiple myeloma, according to
FDA Policy/General
A House appropriations subcommittee has approved by voice vote a bill that includes an additional $41 million for FDA in fiscal year 2021. The vote advances FDA’s budget totaling $3.212 billion in discretionary funding. Total funding for the agency, which includes user fees, is $5.99 billion. “Within