Drugs
Civica says it will manufacture and distribute as early as 2024 three insulins that, once approved, will be available to patients with diabetes at significantly lower prices than products currently on the market. A company statement says it will produce glargine, lispro, and aspart, which are biologics that are interchangeable
FDA Policy/General
Federal Register notice: FDA is permanently debarring Eduardo Navarro from providing services related to an approved or pending drug product application. FDA bases this order on Navarro’s felony conviction related to his conduct as a sub-investigator at Tellus Clinical Research. Navarro and his co-conspirators fabricated medical records
FDA Policy/General
Federal Register notice: FDA is publishing recent information collections that have been approved by OMB. They are: * Labeling Requirements for Human Prescription Drug and Biological Products (0910–0572) * Biosimilar User Fee Program (0910–0718) * Labeling of Certain Beers Subject to the Labeling Jurisdiction of the FDA (0910–0728) * Obtaining Information
Drugs
FDA has published a guidance, Initiation of Voluntary Recalls Under 21 CFD Part 7, Subpart C, to clarify agency recommendations on timely initiation of voluntary recalls and help companies to be “recall ready.” The document discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making
Drugs
A Los Angeles Times analysis is joining the chorus of those raising questions about FDA’s use of accelerated approval pathways for drugs whose benefit has not been shown in clinical trials. The newspaper’s report, reprinted by Yahoo! Finance, says that 14 of the 50 (28%) new drugs approved
Drugs
The 837 medical device recalls in 2021 were 20.2% lower than the 10-year annual average of 1,049 recalls, according to the Sedgwick recall index for 2021. The report shows that software issues remained the top cause for recalls, accounting for 162 events (19.4%). The number of
Drugs
A recent Personalized Medicine Coalition report lists six milestones for 2021 in terms of personalized medicine at FDA. The report says that despite the Covid-19 pandemic, the pace of progress in personalized medicine continues to accelerate as FDA more regularly and rapidly approves diagnostic tools and treatments that expand
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Emergency Use Authorization of Medical Products” (OMB Control Number 0910-0595). The collection helps support implementation of agency policies applicable to authorizing medical products for use in emergencies under sections 564, 564A, and 564B of the Federal
Drugs
Karyopharm Therapeutics says that during a recent meeting with FDA officials, the officials expressed doubt that the results of the SIENDO trial would support approval of an sNDA for the company’s selinexor (Xpovio) as front-line maintenance therapy following chemotherapy in patients with advanced or recurrent endometrial cancer. “Karyopharm
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Inclusion of Older Adults in Cancer Clinical Trials.” The document provides recommendations about including older adult patients (aged 65 and older) in oncology drug clinical trials. It also emphasizes the importance of including adults over age 75 years in
Devices
FDA has approved Johnson & Johnson Vision Care’s Acuvue Theravision with Ketotifen, a drug-eluting contact lens with the antihistamine ketotife. Each lens contains 19 mcg ketotifen which is intended to previde relief from allergic eye itch. The daily disposable contact lenses are indicated for the prevention of ocular
Devices
FDA has cleared a SurGenTec 510(k) for its Ion Screw and its use as a stand-alone spine fixation implant. The device is intended to treat a variety of pathologies throughout the spine from C2-S1. It is smaller than a dime, the company says, and can be inserted
Drugs
Attorney Nick Oberheiden (Oberheiden PC) gives a step-by-step approach for responding to an FDA Warning Letter. In his online post, Oberheiden says FDA enforcement actions can have substantial ramifications, and manufacturers who receive Warning Letters must respond appropriately. “However,” he adds, “this does not necessarily mean jumping into
Biologics
FDA has granted Pfizer a breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, and its use in preventing RSV-associated lower respiratory tract illness in infants from birth up to six months of age through active immunization of pregnant women. The designation is
Drugs
FDA has told Finch Therapeutics that a clinical hold remains in place on its Phase 3 trial of CP101 in recurrent C. difficile infection. The company says an agency 2/24 letter said it needed additional information about Finch’s SARA-CoV-2 donor screening protocols. Since 3/2020 FDA
Drugs
FDA has published a guidance, Pre-Launch Activities Importation Requests (PLAIR), finalizing a 7/2013 draft guidance with the same name. The document describes agency policy on requests for the importation of unapproved finished drug products by an applicant preparing the product for U.S. market launch based on anticipated
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.” The document provides advice on multiple expansion cohort trial designs for investigational oncology drugs. To view the notice, click here.
Drugs
FDA has told Belgium’s Celyad Oncology that it has placed a clinical hold on the company’s CYAD-101-002 (KEYNOTE-B79) Phase 1b trial due to insufficient information to assess the risk to study subjects. The company says it announced on 2/28 that it was voluntarily pausing
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.” The document provides advice to sponsors about the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug and/
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says using registries as part of real-world data (RWD) to support drug and biologic regulatory decision-making “leverages unique, available, and important RWD to understand more about patients and their medical history and can characterize potential benefits and risks in diverse patient
FDA Policy/General
Former FDA director of orphan product development Timothy Cote is petitioning the agency to “immediately and completely freeze all administrative actions on any regulatory requests from pharmaceutical and medical device companies headquartered in Russia or with majority Russian ownership.” His 2/22 emergency petition cites the Russian invasion of Ukraine
Drugs
FDA has released the FDA-483 issued following a 9/15-9/23/21 inspection at OSRX, Inc., a Missoula, MT, producer of sterile drug products. The form contains one observation that the current laminar airflow studies (smoke studies) of the ISO5 laminar airflow workstation were not performed under conditions