Devices
Former FDA commissioner Frank Young died 11/24 at age 88. Young served as commissioner from 1984 to 1989. During his time in office, Young led the agency over several major events, including the Hatch-Waxman Drug Price Competition and Patent Term Restoration Act (1984), and passage of the Prescription
Drugs
A 3/12-3/22 FDA inspection at the Lohxa drug manufacturing facility in Worcester, MA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 9/10 Warning Letter says specific violations were: * failing to establish and follow an adequate written testing program
Devices
A report from the Center for Disease Control and Prevention’s National Healthcare Safety Network says that healthcare-associated infections related to the use of medical devices are more likely to be antibiotic resistant than infections resulting from surgical procedures. The report was published in the Society of Healthcare Epidemiology’
Drugs
CymaBay Therapeutics has terminated a Phase 2b study of seladelpar in subjects with non-alcoholic steatohepatitis and its recently initiated Phase 2 study of seladelpar in subjects with primary sclerosing cholangitis due to safety concerns. In addition, the company is putting on hold all studies of seladelpar in subjects with
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/
Devices
FDA has approved a Tusker Medical PMA for the Tubes Under Local Anesthesia System for delivery of tympanostomy tubes (ear tubes) that can be inserted into the eardrum to treat recurrent ear infections (i.e., otitis media). An FDA release says this is the first ear tube delivery system that
Drugs
Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) have released their ideas for Cures 2.0 legislation to update the 21st Century Cures Act. Upton and DeGette say (contains link to Cures 2.0 document) they are looking for feedback on their proposal and new ideas to consider
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
Drugs
University of Tokyo researchers say the quality of adverse event reports submitted to FDA seems to depend on information costs accrued to potential reporters. They found that the completeness of reports from consumers was generally greater than that of reports from healthcare professionals. “Completeness of specific items varied among different
Drugs
Teva and other generic drug companies have held talks with the federal government over the last six months in an attempt to resolve a long-running criminal antitrust investigation into alleged price-fixing. Bloomberg News reports it has learned from sources familiar with the matter that among the possible outcomes
Drugs
Spherix Global Insights says that approval of a new indication for Janssen’s Invokana, a sodium-glucose co-transporter 2 inhibitor, could lead to a paradigm shift in the way patients with Type 2 diabetes and chronic kidney disease are treated in the future. Invokana was approved to treat Type
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
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