FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS) and Other Deemed Products on the Market Without Premarket Authorization.” The guidance describes, among other things, how FDA intends to prioritize its enforcement resources regarding the marketing of ENDS products that
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species — 21 CFR Part 516” (OMB Control Number 0910-0620). Agency regulations specify the criteria and procedures for requesting eligibility for indexing and for requesting addition to
Drugs
A CDER report on new drug therapy approvals in 2019 shows that the Center used at least one expedited development and review method to speed approval for 60% of the 48 novel drugs approved in 2019. The report says that 17 of the drugs were designated for fast track approval,
Drugs
Commenting on an FDA 11/7/19 public meeting on opportunities and priorities for the CDER Office of New Drugs (OND) in promoting effective drug development programs, BioMarin says OND should support the practice of review teams and division directors who facilitate open, early, and frequent communication between review staff
Biologics
CBER director Peter Marks’ annual report for FY 2019 says the Center approved a novel gene therapy, vaccines, treatments for immune deficiencies, and tests for protection of the blood supply, among other products. The Center approved Zolgensma, the report says, a gene therapy for pediatric patients less than two years
Devices
FDA has cleared an IceCure Medical 510(k) for its Cryoablation Technology and its use to destroy benign and cancerous tumors by freezing them. The device is cleared for treating tumors of the kidney, liver, ear, nose throat and certain neurology areas. Additionally, the clearance also covers the company’s
Devices
FDA has approved Abbott’s new alternative surgical technique for its HeartMate 3 heart pump that will allow more advanced heart failure patients to avoid open heart surgery. Historically, heart pumps have been implanted through open heart surgery, the company says. With approval for an alternative surgical technique, Abbott’s
FDA Policy/General
FDA will hold a 3/27 public meeting to discuss possible agency-level approaches to modernizing FDA’s data strategy, including approaches to data quality, data stewardship, data exchange, and data analytics. A meeting notice says the agency also is soliciting public comments on the topic. A 9/2019 FDA
Drugs
Emery Pharma, an FDA-registered and inspected laboratory, says the agency should issue a regulation, revise industry guidance, and request a recall and suspension of sales of Zantac (ranitidine) and take other steps in response to an Emery study showing that the ranitidine molecule may not be heat stable and,
Drugs
TransCelerate BioPharma says it appreciates the FDA vision for streamlining the IND safety reporting process through direct submission of IND safety reports to the FDA Adverse Event Reporting System (FAERS) and looks forward to implementation. In a draft guidance comment, the company says that during the 24-month transition period
Drugs
Teva is paying $54 million to resolve whistleblower allegations by two former company sales representatives that it used sham paid speaker programs to increase the use of its Copaxone and Azilect. Allegations in the complaint focused on a scheme to induce physicians to write prescriptions for Copaxone and Azilect by
Drugs
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Apollo Health and Beauty Care Ontario, Canada (12/23): FDA inspected the contract manufacturer of over-the-counter drug products and cited
Drugs
FDA has granted Precigen an orphan drug designation for PRGN-3006, a first-in-class investigational therapy for treating patients with relapsed or refractory acute myeloid leukemia (AML). PRGN-3006 uses Precigen’s UltraCAR-T therapeutic platform, which the company says “eliminates ex vivo expansion, reduces manufacturing time and provides
Devices
FDA has cleared a PhotoniCare 510(k) for its TOMi scope for non-invasive imaging of the middle ear. The device uses optical coherence tomography high-resolution depth imaging to determine the presence or absence of fluid in the middle ear and characterize the fluid type, the company says. It
FDA Policy/General
Federal Register notice: FDA has announced a 3/4 Vaccines and Related Biological Products Advisory Committee meeting. Panel members will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2020 to 2021 flu season. Also, they will hear an overview
FDA Policy/General
Federal Register notice: FDA has renewed for two years the charter for its Patient Engagement Advisory Committee. The new charter will be in effect until 10/6/2021. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has renewed for another two years the charter for its Pharmaceutical Science and Clinical Pharmacology Advisory Committee. The new charter will be in effect until 1/22/2022. To view the notice, click here.
Drugs
FDA has issued ViiV Healthcare a complete response letter on its NDA for cabotegravir and rilpivirine, a long-acting regimen for treating HIV-1 infection in virologically suppressed adults. The letter cited chemistry manufacturing and controls (CMC) concerns as the reason for not approving the submission, the company says. “There
Drugs
FDA has approved a Novo Nordisk NDA for Fiasp (insulin aspart injection) 100 u/mL as a mealtime insulin option for children with diabetes. The company says Fiasp is the only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation. It is intended to be
Drugs
FDA has issued Sun Pharmaceutical Industries an eight-observation Form 483 after a December inspection at its Gujarat, India drug manufacturing facility. According to the form, the company was cited for not having written procedures for production and process controls designed to assure that its drug products have the identity,
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its Advisory Committee Membership Nominations (OMB Control Number 0910-0833). FDA selects advisory committee members through a nomination process. A person can self-nominate or be nominated by another individual. The collection also pertains to the agency’
Drugs
Incyte says its pivotal Phase 3 GRAVITAS-301 study evaluating itacitinib in combination with corticosteroids in patients with treatment-naïve acute graft-versus-host disease (GVHD) did not meet the primary endpoint of improving overall response rate compared to placebo plus corticosteroids. Itacitinib added to corticosteroids improved the overall response