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
FDA Policy/General
FDA says its 6/2020 review of the Web site operated by Fishman Chemical of North Carolina, Vero Beach, FL, found that the company sells 11 unapproved new animal drugs. A 7/21 Warning Letter also says the company is continuing to sell chloroquine phosphate, an adulterated new animal drug,
Drugs
FDA says it discontinued the MedWatch to Manufacturers program as of 7/31. Under the program, participating drug and biologic manufacturers could receive information from the agency on serious adverse event reports submitted directly to FDA for new molecular entities and original biologics for the first three years after approval,
Drugs
Public Citizen says that taxpayers invested $70.5 million in the development of Gilead’s remdesivir, which is being used to treat some Covid-19 cases, and thus the company should price the treatment at no more than $1 per day. The advocacy group cited a letter signed by a
Devices
FDA has cleared a Biotricity 510(k) for its Bioflux Software II System. The product is engineered to improve workflows and reduce electrocardiogram (ECG) analysis time from five minutes to 30 seconds, the company says. The Bioflux monitors and transmits an ambulatory patient’s ECG information. It also features “advanced
Devices
HHS secretary Alex Azar 8/4 praised FDA commissioner Stephen Hahn for developing alternative regulatory pathways that could be used to obtain face masks from foreign countries in the early days of the Covid-19 pandemic. Appearing on “Mornings with Maria” on Fox Business, Azar responded to a Wall Street
FDA Policy/General
Federal Register notice: FDA is requesting comments on abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on the availability for medical use of 11 drug substances. The comments will be considered in preparing a response from the U.S. to the World Health Organization (WHO) regarding
Biologics
FDA commissioner Stephen Hahn and deputy commissioner for medical and scientific affairs Anand Shah say the agency has sought to encourage and facilitate the adoption of “advanced manufacturing,” which they say refers to new and emerging approaches for producing medical technologies. Writing in an FDA Voices post, Hahn and Shah
Drugs
GlaxoSmithKline (GSK)and Sanofi have separately disclosed in financial reports that they are being investigated by the U.S. Justice Department over alleged False Claims Act violations in the companies’ marketing and subsequent recall of heartburn drug Zantac (ranitidine). Earlier this year, FDA asked manufacturers (see earlier story) to withdraw
Drugs
Four former FDA commissioners are urging U.S. regulators, researchers and Covid-19-recovered patients to join in an effort to collect blood plasma and begin clinical trials to determine whether the plasma from recovered patients can help those who become sick. Writing in a Washington Post opinion piece, Mark
FDA Policy/General
Federal Register notice: FDA has announced the rates for biosimilar user fees for fiscal year 2021. For example, the fee for a biosimilar application requiring clinical data is $1.7 million, and the initial biological product development fee is $102,000. To view the notice, click here.