Devices
FDA 11/25 announced its Ethylene Oxide Sterilization Master File Pilot Program that is intended to allow companies that sterilize single-use medical devices using fixed chamber ethylene oxide (EtO) to submit a “master file” when making certain changes between sterilization sites or to sterilization processes that utilize reduced EtO
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances for generic drug developers. The guidances provide product-specific recommendations on, among other things, bioequivalence study designs to support ANDAs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on a proposed information collection for “Collection of Information for Participation in FDA Non-Employee Fellowship and Traineeship Programs.” The mandatory collection forms provide FDA with information from the non-employee to begin the program, administer it and coordinate training. To view the
Drugs
FDA has issued a draft guidance on “Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.” The document is intended to clarify what data and information may or may not be needed to support a biosimilarity or interchangeability demonstration for a proposed insulin product. The draft also reflects input from
Devices
FDA has cleared a Renovia 510(k) for its next-generation Leva Pelvic Digital Therapeutic for strengthening pelvic floor muscles and treating stress, mixed and mild-to-moderate urgency urinary incontinence in women. The device uses Renovia’s patented movement-based sensor and app technology to provide women real-time
Drugs
FDA has issued Adamis Pharmaceuticals a complete response letter on its NDA for Adamis’ ZimHi (naloxone) high-dose injection for treating opioid overdose. The letter cited Chemistry, Manufacturing and Controls (CMC) information, the company says, adding that it plans to expand on CMC testing that has already been provided to
Drugs
CDER Office of Prescription Drug Promotion (OPDP) has sent Rockwell Medical an untitled letter after reviewing the company’s Triferic Web page and finding false and misleading information. The page is violative because it presents information about Triferic’s benefits but fails to include any risk information about the drug,
FDA Policy/General
Federal Register notice: FDA has reopened for 20 days the comment period on a 9/25 proposed rule on premarket tobacco product applications and recordkeeping requirements. The proposed rule that would set forth requirements for premarket tobacco product applications (PMTAs) and would require manufacturers to maintain records establishing that their
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.