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 In a draft guidance comment, the company says that during the 24-month transition period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
Devices
FDA has cleared an Applied BioCode 510(k) for its BioCode Respiratory Pathogen Panel (RPP) for use on the BioCode MDx-3000 System. The RPP tests nasopharyngeal swabs for of the most common viruses and bacteria, including Influenza A and subtypes H1, H1N1 2009pdm and H3, Influenza B, respiratory syncytial
FDA Policy/General
Patient Engagement Panel Renewed for 2 Years Federal Register notice: FDA renews for two years the charter for its Patient Engagement Advisory Committee. 01/06/2020 Pharmaceutical Science Panel Charter Renewal Federal Register notice: FDA has renewed for another two years the charter for its Pharmaceutical Science and Clinical Pharmacology
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its guidance on “Special Protocol Assessment” (OMB Control Number 0910-0470). The guidance describes agency procedures to evaluate issues related to the adequacy (e.g., design, conduct, analysis) of certain proposed studies. To view the notice, click
Devices
Cook Medical has recalled (Class 1) its CrossCath Support Catheters due to a manufacturing error which may cause the marker bands to dislodge. A recall notice says that the company has identified that an error occurred during manufacturing which may cause the radiopaque marker bands to be too loose or
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for “Imports and Electronic Import Entries” (OMB Control Number 0910-0046). FDA’s regulations prescribe the required data elements that respondents must submit when importing, or offering for import, an FDA-regulated article into the U.S. The
Devices
Smiths Medical ASD has recalled its Medfusion 4000 Syringe Pumps due to malfunctioning alarms and potential therapy interruption. The company has become aware of a software issue in the most recently updated device firmware, version 1.7.0, that could potentially cause the low battery alarms to stop working, a
Devices
Chembio Diagnostics says it expects FDA approval in two months on its PMA for the DPP HIV-Syphilis System. The single-use, 15-minute screening test simultaneously detects antibodies to HIV Types 1 and 2 and the bacteria that causes syphilis, Treponema pallidum. It uses a 10 microliter sample of
Devices
Several stakeholders are asking FDA to clarify its revised draft guidance on clinical and patient decision support software (CDS). AdvaMed says it is encouraged that the guidance uses a risk-based framework as called for by the 21st Century Cures Act and welcomes the use of several items from the