Drugs
FDA has released the FDA-483 issued following a 7/7-7/21/21 inspection at Tailstorm Health, a Chandler, AZ, 503B outsourcing facility. The inspection observations were: * written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up; * laboratory controls do not include the
Biologics
FDA issued 1/7 a new guidance with recommendations to healthcare providers and investigators on the use of Covid-19 convalescent plasma under the emergency use authorization or investigational convalescent plasma under an IND during the current public health emergency. The document supersedes a 2/2021 guidance and has recommendations
Drugs
FDA and Polynoma have reached agreement under a Special Protocol Assessment on a pivotal Phase 3 clinical trial of the company’s melanoma cancer vaccine seviprotimut-L and its use as an adjuvant treatment for patients 60 years and younger with Stage IIB or IIC melanoma following definitive surgical resection
Devices
FDA has approved a Cochlear Limited PMA for its Cochlear Nucleus Implants for treating unilateral hearing loss and single-sided deafness. According to the company, unilateral hearing loss is classified as hearing loss in one ear and near to near-normal hearing in the opposite ear, and single-sided deafness
FDA Policy/General
As the omicron variant spreads out of control and related hospitalizations are breaking previous Covid-19 records, FDA acting commissioner Janet Woodcock told a Senate Health, Education, Labor & Pensions hearing 1/11 that this is not the time to think about different approaches to combat Covid-19 or determine
FDA Policy/General
Federal Register notice: FDA is correcting a notice in the 11/1/2021 Federal Register that announced the regulatory review period for Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki), indicated for treating adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior
Devices
FDA says consumers should stop using the LuSys Laboratories Covid-19 antigen test (nasal/saliva) and Covid-19 IgG/IgM antibody test because their performance has not been adequately established and there is a high risk of false results from the tests. An agency safety communication says neither test has
Drugs
FDA has approved an Idorsia Pharmaceuticals NDA for Quviviq (daridorexant) 25 mg and 50 mg for treating adult patients with insomnia. The drug is described as a dual orexin receptor antagonist, which blocks the binding of the wake-promoting neuropeptides orexins and is thought to turn down overactive wakefulness, as
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Drug Supply Chain Security Act Implementation” (OMB Control Number 0910-0806). The collection supports the agency’s implementation of provisions in Section 582 of the Federal Food, Drug, and Cosmetic Act regarding the pharmaceutical distribution supply chain.
Devices
FDA has posted a draft guidance entitled Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act. Under Section 506J, FDA requires notification of a permanent discontinuance or interruption in the manufacturing of a device that is likely
Drugs
FDA has removed a clinical hold on Allogene Therapeutics’ AlloCAR T clinical trials. The hold was placed in 10/2021 on five clinical trials involving Allo-501A CAR T cells after a report of a chromosomal abnormality in the company’s ALPHA2 study. The abnormality, which was detected in a
Devices
Cardiovascular Systems has initiated a Class 1 recall of its Wirion system due to complaints about filter breakage during retrieval. The device is used to hold and remove debris or blood clots from the lower limbs that can be associated with atherectomy procedures. “Under certain circumstances, such as when the
Drugs
FDA has granted 4D Molecular Therapeutics a fast track designation for 4D-125 for treating patients with inherited retinal dystrophies due to defects in the retinitis pigmentosa GTPase regulator (RPGR) gene, including X-linked Retinitis Pigmentosa (XLRP). 4D-125 is described by the company as a targeted R100-based product
FDA Policy/General
Public Meeting on Generic Drug User Fees 1/7/2022 Federal Register notice: FDA has announced an 2/16 public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for fiscal years 2023 through 2027. To view the notice, click here. 4 Information Collections
FDA Policy/General
DEVICES FDA has approved a Sientra PMA supplement allowing commercialization of its Opus-branded breast implant products manufactured by Vesta, a Lubrizol LifeSciences company, at Vesta’s Wisconsin-based manufacturing facility. The devices are being made under “an improved manufacturing process,” according to Sientra. FDA has cleared a Varian 510(
FDA Policy/General
GliaCure has begun dosing Alzheimer’s patients in a Phase 1b clinical trial of its GC021109 to evaluate safety and tolerability. The company says its approach promotes the clearance of amyloid and stimulates anti-inflammatory actions through a single target. Bayer HealthCare has entered into an exclusive license agreement with
Drugs
A Texas federal court has ruled against FDA in a Freedom of Information Act (FOIA) lawsuit by Public Health and Medical Professionals for Transparency (PHMPT) looking for data and information on the Pfizer/BioNTech Covid-19 vaccine. The group sued FDA in September after the agency denied its request to
Drugs
FDA has amended the emergency use authorization (EUA) for the Moderna Covid-19 vaccine to shorten the time between the completion of primary vaccination with the product and a booster dose to at least five months. The action aligns the recommended interval for a booster shot with that of the
Drugs
AbbVie has submitted a supplemental NDA for Rinvoq (upadacitinib,15 mg once daily) for treating adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation who have responded inadequately to nonsteroidal anti-inflammatory drugs. The submission is based on data from the Phase 3 SELECT-AXIS
Drugs
CDER is embracing industry’s use of physiologically based pharmacokinetic (PBPK) modeling as an alternative bioequivalence (BE) approach after approving a Perrigo Pharma ANDA for generic diclofenac sodium topical gel that does not include a comparative clinical endpoint BE study. In a just-published regulatory research post, FDA researchers say
Drugs
A Pharmaceutical Research and Manufacturers of America (PhRMA)-funded study finds that more than half (50.5%) of every $1 spent on brand medicines went to payers, middlemen, providers, and other stakeholders in 2020. Adding to the debate on what to reform in hopes of reducing drug prices for patients,
Devices
FDA has cleared a Becton, Dickinson (BD) 510(k) for the BD Kiestra IdentifA system, which is designed to automate preparation of microbiology bacterial identification testing. The device allows lab technicians to use BD Synapsys informatics to select discrete bacterial colonies from a digital plate image, according to the company.