Drugs
Public Citizen is calling on the HHS Inspector General to “investigate the unprecedented and inappropriate close collaboration between FDA and Biogen regarding the company’s application for approval of the Alzheimer’s disease drug aducanumab.” In a 12/9 letter, the advocacy group says that after two identical Phase 3
Drugs
Pfizer says it is pleased with revisions FDA made to a 2010 guidance to eliminate unnecessary testing as shown in a draft guidance on pharmacokinetics in patients with impaired renal function for study design, data analysis, and impact on dosing. A Novartis comment letter says the scope of the draft
Drugs
FDA has awarded a three-year $44.4 million contract to Palantir Technologies to build on the existing partnership with the company to provide an enterprise data management and analytics solution for CDER and the Oncology Center of Excellence. The company says its software will enable information technology leadership, analysts,
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled Best Practices in Developing Proprietary Names for Human Prescription Drug Products. The document describes best practices to help minimize medication errors and otherwise avoid adoption of proprietary names that contribute to agency violations. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products.” The document describes ways to help minimize medication errors and otherwise avoid adoption of proprietary names that contribute to agency violations. It also describes the framework FDA uses
Drugs
FDA says its review of the Web site maintained by Natures Boost, Kirkland, WA, determined that the company is marketing two unapproved new drugs in violation of the Federal Food, Drug, and Cosmetic Act. An 11/20 Warning Letter gives some of the promotional statements from the Web site that
Drugs
FDA says its review of the Web site maintained by Valentus, Inc., Sioux Falls, SD, determined that the company takes orders for several products that the Federal Food, Drug, and Cosmetic Act considers to be unapproved new drugs because they are intended for use in the cure, mitigation, treatment, or
Devices
FDA has released a final guidance on Requesting FDA Feedback on Combination Products. The document discusses ways in which combination product sponsors can obtain feedback from FDA on scientific and regulatory questions and describes best practices for FDA and sponsors when interacting on these topics. The interactions can occur through
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice” (OMB Control Number 0910-0563). The agency’s regulations direct it to establish adequate dispute resolution procedures to ensure appropriate review of scientific
Biologics
Just-released FDA advisory committee briefing information is suggesting that it could be easy sailing for a Pfizer-BioNTech Emergency Use Authorization (EUA)submission for their Covid-19 vaccine. On 12/10, FDA will convene its Vaccines and Related Biological Products Advisory Committee to review and discuss the submitted data.
Devices
FDA has cleared a Zebra Medical Vision 510(k) for its artificial intelligence (AI) analytics that extract bone measurements from X-ray scans for planning orthopedic surgical procedures. The novel technology offers an alternative to CT scans and MRIs for such planning, the company says. Zebra-Med’s technology uses
Drugs
FDA has published the FDA-483 with six inspection observations issued following a 10/7-10/16 agency inspection at Juno Therapeutics, Bothell, WA. The firm is a CAR-T cell therapy manufacturer. The specific inspection observations were: * failing to thoroughly review any unexplained discrepancy, failure of a batch or
Drugs
FDA has issued two guidances on developing proprietary names for human drug products. One guidance covers prescription drug products and the other covers non-prescription products. The documents say they describe best practices to help minimize proprietary name-related medication errors and otherwise avoid the adoption of proprietary names that
Drugs
The American Civil Liberties Union (ACLU) says the Trump administration has told a federal court that Covid-19 is no longer a serious risk and thus FDA is justified in requiring patients seeking mifepristone to go in-person to a clinical setting solely to sign a form and pick up
Drugs
From 6/2019 to 6/2020, the first full year of the FDA Oncology Center of Excellence’s Project Orbis, the effort received 60 oncology marketing applications for either new molecular entities or supplements adding new indications. Of the 60, 38 were approved. Project Orbis is intended to facilitate oncology
Drugs
FDA has granted Turning Point Therapeutics a breakthrough therapy designation for repotrectinib and its use in treating patients with gene ROS1-positive metastatic non-small cell lung cancer (NSCLC) who have not been treated with a ROS1 tyrosine kinase inhibitor (TKI). The designation was based on positive data from the
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Natures Boost, Kirkland, WA (11/20): A recent FDA review of the company’s Web site determined that it is marketing two unapproved new drugs in violation of the
FDA Policy/General
Federal Register notice: FDA has announced the issuance of a priority review voucher to Y-mAbs Therapeutics related to the approval of Danyelza (naxitamab-gqgk). The agency determined that the product met the criteria for a priority review voucher. It is indicated for use in combination with granulocyte-macrophage colony-
Drugs
FDA says it is testing its capability to receive annotated electrocardiogram (aECG) waveform data in electronic format under the Health Level Seven (HL7) Annotated ECG Waveform Data Standard. Those who are interested in voluntarily testing this capability can submit the aECG files directly through the FDA electronic submissions gateway (ESG)
Drugs
FDA is being criticized for its slow response to the need to find alternatives to physical inspections during the worsening Covid-19 pandemic. The issue is even more critical now as a number of drug submission final review actions have been put on the back burner due to the agency’
Drugs
The Justice Department has filed a civil complaint to stop AMARC Enterprises from distributing unapproved and misbranded drugs and adulterated animal drugs. The company sold and distributed “Poly-MVA” and “Poly-MVA for Pets,” which they claim can cure, mitigate, treat, or prevent disease, including cancer. The complaint also alleges
Devices
FDA has issued a safety alert to warn patients and health care providers about patient injuries from wearing face masks that contain metal parts and coatings during a Magnetic Resonance Imaging (MRI) exam. “Metal parts, like nose pieces sometimes called nose clips or wires, nanoparticles (ultrafine particles), or antimicrobial coating