Drugs
Researchers from Harvard Medical School and the University of Pittsburgh say that biomedical company payments to teaching hospitals may raise concerns for institutional conflicts of interest. Writing in Health Affairs, the researchers say that 91% of teaching hospitals received industry payments totaling $832 million in 2018. “We observed substantial royalty
Devices
FDA has approved an early feasibility study for Medtronic’s Intrepid Transcatheter Tricuspid Valve Replacement system in patients with severe, symptomatic tricuspid regurgitation, a disease in which the diseased, damaged, or malfunctioning tricuspid valve allows blood to flow back into the heart’s upper right chamber, causing eventual heart failure
Drugs
An 11/11-11/15/19 FDA inspection at the PT MegaSurya Mas drug manufacturing facility in Sidoarjo, Jawa Timur, (East Java, Indonesia) found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/24 Warning Letter says specific violations were: * failing to have, for each
Drugs
A 3/9-3/12 FDA inspection at the Calvin Scott and Company drug manufacturing facility in Albuquerque, NM, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. An 8/25 Warning Letter says specific violations were: * failing to assure that the drug product bore an
FDA Policy/General
Federal Register notice: FDA has announced a 10/27 virtual public meeting to discuss proposed recommendations for reauthorizing the Medical Device User Fee Amendments (MDUFA) for fiscal years 2023 through 2027. MDUFA authorizes FDA to collect user fees to support the process for reviewing medical device applications. To view the
Drugs
FDA has made availabile a revised draft guidance on Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing. The document is intended to assist sponsors in designing and analyzing drug studies that assess the influence of impaired renal function on pharmacokinetics and pharmacodynamics, and
Biologics
Nine companies developing Covid-19 vaccines have pledged to uphold scientific, regulatory and ethical rigor as they conduct clinical trials and prepare regulatory submissions. The pledge, jointly made by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi, is intended to reassure the public
Drugs
Duke University School of Medicine dermatology professor Meenal Kheterpal is asking FDA to resolve inconsistencies in labeling through class labeling for all currently approved anticancer hedgehog inhibitors. The petition says that all approved hedgehog inhibitors have the same method of action and have comparable safety data supporting their approvals. “As
FDA Policy/General
Lilly says it supports FDA’s determination to take an evidence-informed approach to regulation of direct-to-consumer (DTC) advertising and notes that the agency’s proposed study of multiple indications in DTC television ads “is a complex study with many variables that will be difficult to control.” In
Drugs
FDA has approved an Athena Bioscience NDA for Qdolo (tramadol hydrochloride) oral solution 5mg/1ml, an opioid agonist indicated in adults for managing pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Tramadol in solid oral dosage forms has been marketed widely for over
Drugs
Natco Pharma says it opposes a 4/28 petition filed by Taiho Oncology asking that FDA take specified actions on an ANDA for a generic version of Lonsurf (trifluridine/tipiracil) tablets. The Taiho petition asked that the agency: * refrain from filing or approving an ANDA for Lonsurf tablets that does
Devices
FDA is inviting feedback on information and features that submitters would find useful in a new progress tracker for premarket submissions the agency is developing. An online notice says FDA “is building a secure, Web-based tracker that displays the progress of a medical device marketing submission throughout FDA’s
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. PT MegaSurya Mas, Indonesia (8/24): FDA inspected the firm 11/2019 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to have, for each
Drugs
FDA says that a clinical study shows that Genentech’s Tecentriq (atezolizumab) in combination with paclitaxel does not work to treat patients with previously untreated inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC). An agency statement says Tecentriq in combination with Abraxane is not approved for use in
Drugs
FDA has approved a Genentech NDA for Gavreto (pralsetinib) for treating adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. Gavreto is a once-daily, oral precision therapy designed to selectively target RET alterations, including fusions and
Biologics
As public confidence wanes on potential Covid-19 vaccines, an AstraZeneca and University of Oxford Phase 3 vaccine study has been put on clinical hold due to a serious adverse reaction in a trial participant in the United Kingdom. It is not determined whether FDA or another regulatory agency ordered
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing. The document is intended to assist sponsors in the design and analysis of studies that assess the influence of impaired renal function on the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health” (OMB Control Number 0910-0769). The collection supports information voluntarily submitted to CDRH on actual or potential health risk concerns about a medical
FDA Policy/General
Federal Register notice: FDA has announced a 10/8 joint Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee meeting. Panel members are scheduled to review an Arbor Pharmaceuticals NDA for amphetamine sulfate immediate-release oral capsules and its proposed indication for treating attention deficit hyperactivity disorder.
FDA Policy/General
Federal Register notice: FDA has issued Nippon Shinyaku a priority review voucher after approval of its rare disease drug Viltepso (viltolarsen), indicated for treating Duchenne Muscular Dystrophy in patients amenable to Exon 53 skipping. To view the notice, click here.
Devices
FDA has posted a final guidance entitled Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices — Part 1: Evaluation and Testing Within a Risk Management Process. The document is intended to provide further clarification and updated information on the ISO standard to support applications submitted to FDA.
Biologics
FDA has accepted an Ascendis Pharma BLA for its TransCon hGH (lonapegsomatropin), an investigational long-acting prodrug of somatropin (human growth hormone) for treating pediatric growth hormone deficiency. The submission is supported by data from eight clinical trials evaluating safety and efficacy in more than 400 subjects, Ascendis says. The