Biologics
FDA commissioner Stephen Hahn has written a Washington Post opinion column to reassure Americans that “all FDA decisions (on Covid-19 vaccines) have been, and will continue to be, based solely on good science and data. The public can count on that commitment.” In the column, Hahn says that while
Drugs
The Department of Justice says an Ohio federal grand jury on 7/31 returned a 19-count indictment charging eight people with participating in a scheme to defraud eight drug companies and FDA through conducting fraudulent clinical trials. A department statement says the eight were charged with conspiracy to commit
Biologics
More than 250 experts in virology, epidemiology, vaccinology, infectious disease, clinical care, and public health have signed a letter to FDA commissioner Stephen Hahn urging that no Covid-19 vaccine be made widely available until FDA has been able to evaluate safety and efficacy data from completed Phase 3 clinical
Devices
FDA will hold an 8/12 virtual town hall for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for SARS-Cov-2. An agency notice says the purpose of the town hall is to help answer technical questions about the development and validation of tests
Drugs
The White House says President Trump is signing 8/6 an Executive Order to increase American production of essential medical supplies and cut down U.S. reliance on foreign drug producers. Under the order, FDA is directed to create a list of drugs, medical countermeasures, and “critical inputs” that are
Devices
FDA has cleared a Surmodics 510(k) for its Sublime Radial Access 0.014 Rapid Exchange percutaneous transluminal angioplasty dilatation catheter. The device allows below-the-knee access through a transradial approach by providing a long working length (250 cm), according to the company. Outer balloon diameters range from 2.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Extralabel Drug Use for Animals — 21 CFR 530” (OMB Control Number 0910–0325). The collection supports FDA’s requirement that an analytical method be developed for detecting residues from the extralabel use of a drug. To view the
Drugs
The Justice Department is pursuing claims against Purdue Pharma worth nearly $13 billion in penalties, after finding evidence of criminal and civil misconduct in the company’s alleged role in fueling the opioid crisis in the U.S. Reuters reports in an exclusive story that the details of the government’
Devices
FDA has cleared a Life Spine 510(k) for the Plateau-A Ti Anterior Lumbar Spacer System, intended for use for anterior fusion procedures. The company says the device comes in multiple footprint sizes and in various heights to accommodate individual patient anatomies and pathologies to promote fusion. It features
Devices
CME America has recalled its BodyGuard Infusion Pump System because the device may have a slower than expected delivery of medication (under-infusion), faster than expected delivery of medication (over-infusion) or a delay in therapy. A recall notice says the reason for the infusion errors is not known. “Depending
Devices
FDA has cleared a Siemens Healthineers 510(k) for the Somatom On.site, a mobile head computed tomography scanner that is intended to scan critically ill patients in the intensive care unit while remaining in bed. The company says the device features an easy scan setup, fast workflow, and integrated
Biologics
AbbVie has terminated its Alzheimer’s and Parkinson’s disease therapy development agreements with Voyager Therapeutics. In a Securities and Exchange Commission filing, Voyager says it was informed 7/28 that its agreements with AbbVie that were reached in 2018 and 2019 would end on 8/3. “In each case,
Drugs
The Biotechnology Innovation Organization (BIO) says it appreciates FDA efforts to address challenges associated with developing therapies for rare diseases that do not yet have treatments but, given the number of identified rare diseases, is concerned and has questions about the potential scope of a single rare disease clinical trial
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Postmarketing Information Sharing Among Constituent Part Applicants for Combination Products — 21 CFR 4.103” (OMB Control Number 0910–0834). Under the collection, constituent part applicants must share safety information they receive related to certain events with the
FDA Policy/General
Federal Register notice: FDA is seeking applicants to participate in an Office of Combination Products (OCP) voluntary pilot program to help it evaluate a new electronic submissions process for Requests for Designation (RFD) and Pre-RFD. OCP plans to accept up to nine participants for the pilot program. To view
FDA Policy/General
Federal Register notice: FDA has announced fiscal year 2021 user fee rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities. For example, the non-small business establishment fee is $18,837, and the re-inspection fee for
Drugs
The Biotechnology Innovation Organization (BIO) says it supports FDA efforts to modernize its data strategy to ultimately transform the way data is shared, analyzed, and used for regulatory purposes. Commenting in advance of an agency public meeting on the topic, BIO says it will be important to remember that just
Drugs
FDA has released the FDA-483 issued following a 5/28-29 and 6/1-6/15 inspection at MasterPharm, a South Richmond Hill, NY, producer of sterile and non-sterile drug products. The report’s inspection observations were: * releasing drug product in which the strength differs from, or its
Drugs
FDA has published a guidance, Limited Population Pathway for Antibacterial and Antifungal Drugs, with information on how the agency is implementing a section of the 21st Century Cures Act that established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway). The document is intended to assist sponsors in
FDA Policy/General
Federal Register notice: FDA has announced the rates for generic new animal drug user fees for fiscal year 2021. For example, the fee for an abbreviated application for a generic new animal drug is $513,000, and the generic new animal drug sponsor fee is $202,000. To view the
FDA Policy/General
Federal Register notice: FDA has announced the fee rates and payment procedures for fiscal year 2021 animal drug user fees. For example, the New Animal Drug Application fee is set at $575,000 and the Supplemental Animal Drug Application fee is $287,000. To view the notice, click here.
Drugs
A 2/25-3/20/19 FDA inspection at Acrx Specialty Pharmacy, Las Vegas, NV, found multiple violations of drug compounding and other provisions of the Federal Food, Drug, and Cosmetic Act in the production of finished drugs. A 7/24 Warning Letter says Acrx failed to meet requirements for