Drugs
FDA has issued Eli Lilly a three-item Form FDA-483 after aseptic processing deficiencies were identified during a 10/17-21/2022 inspection at the Lilly Technology Center in Indianapolis, IN. The heavily redacted inspection form cited the firm’s “deficient” aseptic technique associated with a drug product filling
Drugs
FDA has released a final guidance on Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy (NRT) Drug Products. The agency says the guidance includes “several innovations in the regulatory pathway for NRT drug products. For example, the guidance discusses ‘reduction in risk of relapse’ as a potential indication to
FDA Policy/General
Federal Register notice: FDA is extending the comment period associated with a 4/13 notice requesting feedback on the FDA Data and Technology Strategic Plan. Comments now can be submitted through 6/12. To view the notice, click here.
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) is planning a direct-to-consumer drug advertising survey to understand the tradeoffs made by diagnosed consumers and how those tradeoffs differ from the tradeoffs made by physicians on the drugs to use/prescribe. “The proposed research examines the relative importance of
Drugs
FDA has approved Pfizer’s Prevnar 20 (20-valent pneumococcal conjugate vaccine) for the prevention of invasive pneumococcal disease caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine for use in infants and children aged six weeks through 17 years. It is also approved for preventing otitis
Devices
The Center for U.S. Policy (CUSP) has filed a Citizen Petition asking FDA to deem a widely used clinical decision support software, Bamboo Health’s NarxCare, a misbranded medical device and to mandate a recall to prevent serious, adverse health consequences and death. The software is a substance use
Biologics
FDA has released an International Council for Harmonization final guidance entitled “S12 Nonclinical Biodistribution (BD) Considerations for Gene Therapy Products.” It provides harmonized recommendations for the overall design of nonclinical BD assessments. Considerations for interpretation and application of the BD data to support a nonclinical development program and the design
Drugs
Teva Pharmaceuticals has recalled 13 lots of various strengths of fentanyl buccal tablets due to safety updates that were omitted in the product insert/medication guide materials that are provided with the affected lots. Teva manufactured and labeled the products exclusively for Mayne Pharma, a recall notice says. The notice
Drugs
FDA has approved an Otsuka America Pharmaceutical and Lundbeck NDA for Abilify Asimtufii (aripiprazole) a once-every-two-months injection for treating schizophrenia in adults or for maintenance monotherapy treatment of Bipolar I disorder in adults. The companies note that the extended-release intramuscular injectable suspension is not approved for
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) is planning to research issues related to using endorsers in direct-to-consumer TV ads for prescription drugs. A Federal Register notice says the research will examine the influence of two independent variables — endorser type (patient or doctor) and actual-use disclosure
Drugs
Eli Lilly says that following positive results from the Phase 3 SURMOUNT-2 trial, it plans to complete in coming weeks an FDA submission for its tirzepatide in adults with obesity or overweight with weight-related comorbidities. A company statement says tirzepatide achieved up to 15.7% weight loss in
Drugs
The Better Business Bureau’s National Advertising Division (NAD) has sent superiority claims made in ads for ViiV’s HIV drug Dovato (dolutegravir/lamivudine) to FDA and the Federal Trade Commission for review after the company declined to participate in an NAD self-regulatory process on the claims. The NAD
Drugs
Bipartisan legislation to make the U.S. pharmaceutical supply chain less dependent on China and other foreign countries has been reintroduced by Reps. Earl Carter (R-GA), Darren Soto (D-FL), Carol Miller (R-WV), and Matt Cartwright (D-PA). A statement (includes a link to the bill text) issued
Devices
FDA has granted Ultromics a breakthrough device designation for its artificial intelligence (AI)-supported platform for detecting cardiac amyloidosis. The EchoGo Amyloidosis uses AI to analyze echocardiograms and detect cardiac amyloidosis, a condition caused by abnormal protein deposits in the heart tissue. The process is completed using a single, commonly
Devices
FDA has issued an alert about a cybersecurity vulnerability affecting the Universal Copy Service software in the Illumina MiSeqDx, NextSeq 550Dx, iScan, iSeq 100, MiniSeq, MiSeq, NextSeq 500, NextSeq 550, NextSeq 1000/2000, and NovaSeq 6000 sequencing instruments. The devices are specified either for clinical diagnostic use in sequencing a
Drugs
FDA has approved a Seres Therapeutics BLA for Vowst (fecal microbiota spores, live-brpk), formerly called SER-109, an orally administered microbiota-based product to prevent recurrence of C. difficile Infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI). The product is not indicated for treating CDI, according
Drugs
Public Citizen has petitioned FDA to promptly add Covis Pharma’s Makena (hydroxyprogesterone caproate) and its generics to the official list of drugs withdrawn or removed from the market because they were deemed unsafe or ineffective. A statement (contains a link to the petition) says the action is necessary to
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection entitled “Records and Reports Concerning Experiences with Approved New Animal Drugs: Adverse Event Reports.” The collection supports statutory and regulatory requirements covering adverse events and product/manufacturing defect reporting associated with approved new animal drugs. To view the notice,
Drugs
Rep. Kirsten Gillibrand (D-NY) has introduced bipartisan legislation to expedite provisional FDA approval of drugs intended to treat ALS (amyotrophic lateral sclerosis), Parkinson’s, Alzheimer’s, and other life-threatening illnesses. In a statement, Gillibrand says the standard FDA approval process takes many years to get drugs to market,
Drugs
A Parenteral Drug Association (PDA) online post says discussion with industry members demonstrates ongoing concerns about CDER’s Quality Management Maturity (QMM) program that was approved at an 11/2-11/3/22 meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. The post says QMM is intended to
Drugs
FDA has cleared two 510(k)s from 3M Health Care for its 3M Veraflo Cleanse Choice Complete Dressing and 3M VAC Veraflo Cleanse Choice Dressing, which the company describes as negative pressure wound therapies. 3M says the dressings received the first-ever clearance for hydromechanical removal of infectious materials,
FDA Policy/General
FDA has published a guidance, Registering with CVM’s Electronic Submission System, with general standards that the agency says should be used to register with the Center’s electronic submission system (ESS). The document says CVM’s ability to receive and process information submitted electronically is limited by its current