Drugs
The Justice Department says that Heather Alfonso, who worked as an advanced practice registered nurse in a Connecticut pain management center, has been sentenced by a Connecticut federal judge to three years of probation for engaging in a kickback scheme related to fentanyl spray prescriptions. A department statement says that
FDA Policy/General
Federal Register notice: CDRH has announced an Ethylene Oxide Sterilization Master File Pilot Program that will allow sterilization providers 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 when making certain changes to sterilization
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products.” The document describes FDA’s compliance policy for premarket review requirements for two types of limited modifications to new tobacco products that were on the market as of 8/8/
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. EPH Technologies, Silver Spring, MD (11/18): After reviewing company-operated Web sites, FDA determined that its Detoxoplex, Sinoplex and Migrenza products are unapproved new drugs. For example, Detoxoplex
FDA Policy/General
The Alliance for a Stronger FDA says consideration should be given to FDA staff as we sit down for Thanksgiving dinner this week. “ Consider adding thanks to FDA and its devoted staff, including the inspectors who never get sufficient credit for the difficulty and potential danger in their jobs,” the
FDA Policy/General
FDA has named Kaveeta Vasisht as associate commissioner for women’s health. The announcement says she joined the Office of Women’s Health earlier this year and has been the acting associate commissioner and deputy director for the past nine months. Trained as both a physician and a pharmacist, Visisht
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
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
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
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
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
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