FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “FDA Recall Regulations — 21 CFR Part 7” (OMB Control Number 0910-0249). The collection pertains to product recalls, which may be undertaken voluntarily and at any time by manufacturers and distributors, or at the request of the
FDA Policy/General
Federal Register notice: CBER is announcing the availability of version 2.2 of the “Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports (ICSRS) for Vaccines.” The version update is not applicable to CBER-regulated drug products marketed with approved NDAs and ANDAs; CBER-regulated therapeutic biological products marketed
FDA Policy/General
Retired FDA psychiatry products director Thomas Laughren has joined BetterLife Pharma as a regulatory advisor. BetterLife describes itself as an emerging biotechnology company developing second generation psychedelics for neuro-psychiatric disorders. It is also refining and developing drug candidates from a broad set of complementary interferon-based technologies which have
Drugs
Bristol Myers Squibb says there were positive topline results in the Phase 3 CheckMate-648 trial evaluating treatment with Opdivo (nivolumab) plus chemotherapy or Opdivo plus Yervoy (ipilimumab) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma. A company statement says that in the study Opdivo demonstrated a
Biologics
FDA has granted Gilead Sciences full approval for Trodelvy (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. The approval is based on data from
Biologics
FDA has posted a five-observation Form FDA-483 from a 4/2020 inspection at troubled contract manufacturer Emergent Biosolutions’ Baltimore manufacturing facility. Last week, Johnson & Johnson sent quality and compliance experts to help Emergent after 15 million doses of J&J’s Covid-19 vaccine (see earlier
Biologics
CBER has issued the Fiscal Year 2020 annual summary of biological product and human cells, tissues, and cellular and tissue-based products (HCT/P) reports. The annual summary gives an overview of the reports submitted during the fiscal year, including detailed information on the number and types of deviation reports.
FDA Policy/General
FDA and the Federal Trade Commission say their review of Web sites and social media sites maintained by Allure Imports, Sault Sainte Marie, MI, established that the company markets products that are intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in humans or animals. A 4/7 Warning
Drugs
National Institute on Aging (NIA) researchers are looking into whether drugs already approved by FDA for indications other than dementia can be used to help prevent or treat Alzheimer’s disease. An NIA statement says the Drug Repurposing for Effective Alzheimer’s Medicines (DREAM) study research team has identified a
Devices
A New Jersey federal court has reiterated that plaintiffs challenging the safety or effectiveness of Class 3 medical devices with premarket approval can’t rely on the res ipsa loquitur (occurrence of an accident implies negligence) doctrine to satisfy their pleading obligations. Attorney Andrew Tauber (Winston & Strawn) writes in
Biologics
Two Mintz attorneys say it will be important to watch and see what new leadership at HHS and Democrats and Republicans in Congress will do with a 3/31 letter from special counsel Henry Kerner to President Joe Biden faulting the way FDA handled a Team Biologics whistleblower complaint that
Devices
CDRH posted on 4/6 two new training modules for the Medical Device Single Audit Program. The first covers the measurement analysis and improvement process under the MDSAP. The presentation says that the purpose of an organization’s measurement, analysis, and improvement process is to collect and analyze information, identify
Biologics
AbbVie has submitted a supplemental BLA for Skyrizi (risankizumab-rzaa) 150 mg for treating adults with active psoriatic arthritis. The submission is based on data from two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, showing that Skyrizi demonstrated significant improvements in disease activity, skin clearance and physical function
Drugs
In what some industry observers say may be a sign that FDA is ramping up foreign inspections after a year-long hiatus due to the Covid-19 pandemic, WuXi Biologics says it successfully completed both an FDA pre-license inspection and a routine FDA GMP (good manufacturing practice) inspection at
Drugs
Ongoing FDA safety concerns with JAK inhibitors are causing review extensions for Eli Lilly/Incyte and Pfizer submissions. The drug class concerns arose from an FDA-required safety study when Pfizer’s Xeljanz (tofacitinib) was approved in 2012 for rheumatoid arthritis. In 2/2019 and 7/2019, FDA warned that
Devices
A majority of the members of the FDA Circulatory Systems Device Advisory Panel has voted to support FDA PMA approval of the TransMedics OCS heart system for donor hearts currently utilized and unutilized for transplantation. The panel voted 12-5-1 that the benefits of the system outweigh its risks,
Biologics
FDA has recommended an early termination for a ERC-USA and University of California, Irvine, Phase 2 trial of ERC 1671 (Gliovac or Sitoiganap) for treating glioblastoma and recommended that the parties pursue a confirmatory Phase 3 registration trial to support a BLA application. ERC-USA says the agency advice
Devices
FDA has approved Bausch + Lomb’s ClearVisc dispersive ophthalmic viscosurgical device (OVD) for use in ophthalmic surgery. OVDs aid in cataract extraction and intraocular lens (IOL) implantation by creating and maintaining space, aiding in tissue manipulation, enhancing visualization, and protecting the corneal endothelium and other intraocular tissues, the company says.
Drugs
FDA has approved a new dosage regimen — 120-minute intravenous infusion every two weeks — for Imclone’s Erbitux (cetuximab) for treating patients with K-Ras wild-type, EGFR-expressing colorectal cancer or squamous cell carcinoma of the head and neck. This dosage option is in addition to the previously approved
Drugs
Qmart (Elmwood Park, NJ) has recalled all lots of its Imperial Gold 2000, PremierZen Extreme 3000, Burro en Primavera 60000 and Imperial Platinum 2000 after an FDA analysis found the products to be tainted with undeclared sildenafil and/or tadalafil, which are ingredients known as phosphodiesterase (PDE-5) inhibitors found
Drugs
The FDA Cardiovascular and Renal Drug Advisory Committee will consider a FibroGen NDA for roxadustat to treat anemia of chronic kidney disease in both dialysis-dependent and non-dialysis-dependent patients on 7/15. The company says its NDA is supported by positive results from a global Phase 3 program
Drugs
The CBER Office of Compliance and Biologics Quality says its review of a Web site maintained by Curex, Inc., New York, NY, determined that the firm markets mixtures of allergenic extracts intended for sublingual immunotherapy. A 3/23 Notice of Violation says the Web site refers to the products as