Drugs
FDA has accepted for priority review an Intercept Pharmaceuticals NDA for obeticholic acid (OCA) seeking accelerated approval for treating fibrosis due to nonalcoholic steatohepatitis (NASH). “If approved, OCA would be the first available therapy for patients with fibrosis due to NASH, a condition that is expected to become the leading
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.” The guidance reflects revised statutory provisions for requesting certificates under the 21st Century Cures Act. The certificates are intended to help protect the
FDA Policy/General
Info Collection on FOIA Identity Form Federal Register notice: FDA seeks comments on an information collection extension for “Certification of Identity; Form FDA 3975.” 11/22/2019 Info Collection for Device Shortage Data System Federal Register notice: FDA sends to OMB an information collection for “Medical Devices; Shortages Data Collection
FDA Policy/General
KalVista Pharmaceuticals, a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, has entered into a collaboration agreement with Merck. The agreement will seek to advance KalVista’s investigational intravitreal injection candidate currently in development for treating diabetic macular edema. China Biologic has
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Certification of Identity; Form FDA 3975” (OMB Control Number 0910-0832). The collection supports “Certification of Identity” forms, which are used by FDA to identify an individual requesting a particular record under the Freedom of Information Act
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection for “Medical Devices; Shortages Data Collection System” (OMB Control Number 0910–0491). Previously, CDRH identified the need to acquire and maintain detailed data on domestic inventory, manufacturing capabilities, distribution plans, and raw material constraints for medical devices that would
Drugs
U.S. Justice Department has announced that a foundation based in Orlando, FL has agreed to pay $4 million to resolve allegations that it violated the False Claims Act by enabling certain pharmaceutical companies to pay kickbacks to Medicare patients taking the companies’ drugs. The Assistance Fund (TAF) conspired with
Biologics
CBER Office of Compliance and Biologics Quality has issued RichSource Stem Cells an untitled letter over promotional statements on its Web site (https://richsourcestemcells.com) for cell therapy and “regenerative therapy” RichGen. The letter says that the product also does not have an approved BLA. “We note that your product
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “General Licensing Provisions; Section 351(k) Biosimilar Applications; Formal Meetings Between the FDA and Sponsors or Applicants” (OMB Control Number 0910–0719). The revision is related to certain performance goals under the FDA Reauthorization Act of 2017
Drugs
FDA has accepted for review an Endo International BLA for collagenase clostridium histolyticum (CCH) for treating cellulite in the buttocks. The submission is based on data from two identical Phase 3 RELEASE studies that demonstrated a greater percentage of the 843 women treated during the studies met the primary endpoint
Drugs
President Trump has signed a short-term continuing resolution that funds FDA and other agencies at FY 2019 funding rates through 12/20. For now, a government shutdown was averted and more time is available to advance pending spending bills. As previously discussed, the Alliance for a Stronger FDA has
Drugs
FDA has approved a SK Life Science NDA for Xcopri (cenobamate tablets) for treating partial-onset seizures in adults. Approval was based on data from two randomized, double-blind, placebo-controlled studies that enrolled 655 adults. “In these studies, patients had partial-onset seizures with or without secondary generalization for
Devices
FDA has posted a summary of the deliberations during an 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee meeting, which recommended (see earlier story) that FDA should require dentists to move away from using mercury-containing amalgams and towards non-mercury containing products like composite materials
FDA Policy/General
HHS has published a list of rules in the proposed and final stages of consideration. The list includes 85 items from FDA.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Transdermal and Topical Delivery Systems — Product Development and Quality Considerations.” The document provides recommendations on the pharmaceutical development and quality information to include in NDAs and ANDAs. Specifically, it discusses product design and pharmaceutical development, manufacturing process and control,
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a proposed information collection on “Web-Based Pilot Survey To Assess Allergy to Cosmetics in the United States.” The agency notes that no publicly available data have been collected on the prevalence of adverse reactions to cosmetic products since 1975. The proposed
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for its “Guidance for Industry on Dear Health Care Provider Letters: Improving Communication of Important Safety Information” (OMB Control Number 0910-0754). The collection supports recommendations in the guidance, which provides instruction to industry and FDA staff on
Drugs
FDA has released the FDA-483s issued following inspections at Aurobindo Pharma Units 5 and 8. The inspection at Unit 5 in Telangana, India, ran from 10/21-10/28 and resulted in four inspection observations: * laboratory controls do not always include the establishment of scientifically sound and appropriate procedures
Drugs
As part of the Project Orbis collaboration with the Australian Therapeutic Goods Administration and Health Canada, FDA has granted supplemental approval to AstraZeneca’s Calquence (acalabrutinib) for treating adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. An agency statement says Project Orbis provides a framework for concurrent submission and
Drugs
Washington Legal Foundation (WLF) is urging the U.S. Court of Appeals for the DC Circuit to affirm a decision blocking an HHS rule that would require drug makers to include the wholesale acquisition cost (defined by HHS as the “list price”) of any drug advertised in direct-to-consumer
Drugs
A new report by the National Academy of Sciences recommends that regulators like FDA “need to make increased use of reliance and cooperation with other trusted regulators, as no regulator has the resources it needs to meet all of its public health responsibilities.” The report also said “(i)mpediments to
Devices
FDA has cleared a Siemens Healthineers 510(k) for the Somatom X.cite premium single-source computed tomography scanner and its myExam Companion user interface. The device works by guiding users through the exam workflow with precise questions about the patient, for example, a patient’s electrocardiogram waveform for a