Devices
FDA has posted test performance data from four antibody, or serology, test kits from an independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI). The data are among the first to come from a collaborative effort by FDA, NIH, Centers for Disease
Drugs
FDA has granted AlgoTherapeutix an orphan drug designation for ATX01 (topical amitriptyline) for treating erythromelalgia. The rare condition primarily affects the feet and less commonly the hands. It is characterized by intense, burning pain, severe redness and increased skin temperature either episodic or almost continuous. The company says the ATX01
Devices
FDA has reissued certain emergency use authorizations (EUAs) to identify specific respirators that can be decontaminated for reuse. “Based on the FDA’s increased understanding of the performance and design of these respirators, the FDA has decided that certain respirators should not be decontaminated for reuse by health care personnel,
Drugs
A new FDA drug quality annual report says that FDA in 2019 performed 1,258 drug quality surveillance inspections, with 42% of these conducted in the U.S. Inspections in the European Union were next on the list with 17% conducted there, followed by India (15%), China (9%) and the
Drugs
CDER Office of Antimicrobial Products (OAP) deputy director John Farley has been appointed permanent director. He had been serving as acting director since 8/2019 when former director Edward Cox left the agency to join Regeneron as regulatory affairs vice president. Cox had served as OAP director since 2006, after
Drugs
FDA has issued a guidance entitled “Temporary Policy on Prescription Drug Marketing Act (PDMA) Requirements for Distribution of Drug Samples During the Covid-19 Public Health Emergency.” Under the policy, which is effective during the Covid emergency, FDA says it will not take action against a manufacturer or authorized distributor
FDA Policy/General
A Nevada federal court 7/10 entered a consent decree of permanent injunction against Las Vegas-based Bio Health Solutions and its manager/co-owner, Mark Garrison, for selling RenAvast, an unapproved animal drug. According to FDA’s complaint, the firm has marketed RenAvast to treat diseases, including chronic renal
Devices
FDA has approved an Abiomed IDE to start an early feasibility study with a first-in-human trial of the 9 French Impella Expandable Cardiac Power (ECP) heart pump. The device will be studied in high-risk percutaneous coronary intervention (PCI) patients, the company says. Impella ECP is the world’
FDA Policy/General
Federal Register notice: FDA has announced a 7/23 virtual public meeting on “Reauthorization of the Prescription Drug User Fee Act.” The meeting will discuss proposed recommendations for reauthorizing the Prescription Drug User Fee Act (PDUFA) for fiscal years 2023 through 2027. A public docket has also been established for
Drugs
FDA has added a new section to a clinical trial guidance on 21 CFR Part 11 compliance for electronic systems used to generate electronic signatures on clinical trial records. The added content is contained in a question-and-answer appendix in the guidance titled “Conduct of Clinical Trials of Medical
Devices
FDA has posted a revised guidance entitled “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (Covid-19) Public Health Emergency.” The revision is intended to articulate agency policy to help expand the availability and capability of non-invasive remote monitoring
Drugs
FDA has announced a 6/30 virtual meeting entitled “Regulated Bioanalysis Workshop: Requirements and Expectations.” This training is focused on presenting an overview of how CDER approaches different issues in bioanalysis. Attendees are expected to gain an understanding of how bioanalysis must be performed to adequately support regulated activities and
Drugs
FDA has accepted for review an Adamas Pharmaceuticals supplemental NDA for Gocovri (amantadine) as a treatment for “off” episodes in Parkinson's disease (PD) patients receiving levodopa-based therapy. Currently, Gocovri (amantadine) is approved to treat dyskinesia in such patients, with or without other dopaminergic medications. In the submission,
Devices
FDA has cleared a Transit Scientific 510(k) for its XO Score Percutaneous Transluminal Angioplasty (PTA) Scoring Sheath platform for use in iliac, ilio-femoral, popliteal, infra-popliteal, and renal arterial plus synthetic or native arteriovenous hemodialysis fistula procedures. Angioplasty is performed with expandable polymer balloon catheters to dilate stenosed,
FDA Policy/General
Federal Register notice: FDA is correcting a 5/27 notice on a guidance entitled “Q3C (R8) Recommendations for the Permitted Daily Exposures for Three Solvents--2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and Tert-Butyl Alcohol — According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents.” The date on page
FDA Policy/General
Federal Register notice: FDA has announced the issuance and reissuance of Emergency Use Authorizations (EUAs) for certain medical devices related to the Covid-19 public health emergency. FDA has issued, and in some cases reissued, EUAs listed in the notice, which includes conditions on the emergency use of the authorized
Devices
FDA has issued a PowerPoint presentation, Testing Supply Substitution Strategies, describing a new Web resource for labs performing Covid-19 tests that are authorized. The slide show says the resource includes validated supply alternatives that labs can use to continue performing testing when there is a supply issue with some
Drugs
FDA has granted Fitbit an emergency use authorization for its emergency ventilator, Fitbit Flow, for use during the Covid-19 public health emergency. The device is modeled after “standard resuscitator bags, like those used by paramedics, with sophisticated instruments, sensors, and alarms that work together to support automated compressions and
Drugs
FDA is reminding laboratory staff to use transport media that are compatible with Covid-19 testing platforms and the processes used in their laboratory to process samples collected. “There is a risk of exposure to harmful cyanide gas, a by-product of a reaction between guanidine thiocyanate or similar chemicals
Drugs
Harvard Medical School researchers say that manufacturers of investigational antimicrobial products frequently qualified for expedited testing and review programs offered by FDA. Writing in The Lancet Infection, the researchers say that since 2012 FDA has promulgated antimicrobial-specific guidance documents that reiterate the agency’s ongoing commitment to regulatory flexibility
Biologics
A Public Citizen analysis finds that all five of the Trump administration’s short-list picks for a Covid-19 candidate vaccine have benefited from substantial public funding. A news release from the advocacy group identifies the vaccine manufacturer candidates as AstraZeneca (with Oxford University), Moderna (with the National Institutes
Drugs
India-based Aurobindo Pharma says that an FDA inspection earlier this year at its oral solid manufacturing facility in Dayton, NH, AuroLife Pharma, resulted in a Form 483 citing nine GMP observations. The agency notified the company that the 1/13 to 2/12 inspection was classified as “official action