FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Contact Dermatitis From Topical Drug Products for Cutaneous Application: Human Safety Assessment.” The document provides recommendations for characterizing topical drug product safety regarding the risk for contact dermatitis. The recommendations are directed toward development of topical new drug products
Drugs
FDA has released a final report from an agency-contracted sampling of talc-containing cosmetic products for the presence of asbestos. The testing was performed by AMA Analytical Services. The results showed that 43 samples were negative while nine were positive. “In the case of the positive samples, when the
FDA Policy/General
Federal Register notice: FDA has reopened until 5/5 the comment period for a 11/7/2019 notice on a draft document entitled “Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff.” The document discusses risk-based principles that support ongoing FDA postmarketing safety surveillance for
Drugs
FDA has issued a new draft guidance on “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control” that proposes to remove a previous recommendation that sponsors of all new therapies for Type 2 diabetes uniformly rule out risks for ischemic cardiovascular adverse outcomes (cardiovascular outcome
Drugs
FDA has accepted for review a Mylan/Biocon BLA for MYL-1402O, a biosimilar candidate referencing Genentech’s Avastin (bevacizumab). Avastin is indicated for treating five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell
FDA Policy/General
Federal Register notice: FDA has announced a 4/3 public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting aims to provide information and solicit public input on
Drugs
FDA has approved Boehringer Ingelheim Pharmaceuticals’ Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype. “Chronic fibrosing ILD with a progressive phenotype encompasses a group of fibrotic lung diseases caused by different underlying diseases or conditions, including autoimmune ILD, hypersensitivity pneumonitis
FDA Policy/General
Draft Guide on Including Older Patients in Trials Federal Register notice: FDA makes available a draft guidance entitled “Inclusion of Older Adults in Cancer Clinical Trials.” 03/06/2020 Policy for Coronavirus Testing Labs Federal Register notice: FDA makes available a final guidance entitled “Policy for Diagnostics Testing in Laboratories
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Inclusion of Older Adults in Cancer Clinical Trials.” The document provides recommendations about including older adult patients in drug oncology clinical trials. It emphasizes the importance of including adults over age 75 years. The guidance also includes recommendations for
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency.” The document describes a policy for laboratories using tests they develop
FDA Policy/General
Federal Register notice: CDER has announced its decision to continue the (XXX INSERT XXX) Regulatory Project Management Site Tours and Regulatory Interaction Program. The program gives CDER (XXX DELETE XXX) managers the opportunity to tour pharmaceutical facilities to learn more about drug development processes and to share information about project
Devices
FDA has classified as Class 1 a Becton Dickinson/CareFusion recall of 774,000 Alaris System infusion pumps and modules due to software and system errors. According to a recall notice, the devices have experienced low battery alarm failures, “Keep vein open/End of Infusion” alarm priority errors, custom concentration
Devices
The Justice Department has filed two False Claims Act lawsuits against SpineFrontier and related entities and executives, alleging that the company paid kickbacks to spine surgeons to induce the use of SpineFrontier surgical devices, which is in violation of the Anti-Kickback Statute. According to the complaint, defendants paid spine
Drugs
FDA has released a draft guidance (XXINSERT LINKXX) on “Contact Dermatitis from Topical Drug Products for Cutaneous Application: Human Safety Assessment.” The document discusses local safety assessments for the risk of contact dermatitis (irritant, allergic, and photoallergic) when developing topical drug products. The recommendations were developed based in part on
FDA Policy/General
Federal Register notice: FDA has finalized a ban on electrical stimulation devices (ESDs) for self-injurious or aggressive behavior. FDA has determined that the devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. The ban includes both new and already
Devices
U.S. Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) have introduced the bipartisan Verifying Accurate, Leading-edge IVCT Development Act that is intended to increase diagnostic testing capabilities to better respond to emerging public health threats, like the coronavirus. The bill would codify FDA’s recent temporary
Drugs
Hikma Pharmaceuticals has extended a previously announced recall of certain lots of ketorolac tromethamine injection USP 30mg/mL, 1mL fill/2mL vials due to the presence of small visible particulate matter (a gelatinous/oily nature that appears black in some of the recalled lots). In December, Hikma voluntarily recalled the
Drugs
FDA has published a draft guidance, Inclusion of Older Adults in Cancer Clinical Trials, with recommendations regarding the inclusion of older adult patients in clinical trials of drugs to treat cancer. Specifically, the document says it has recommendations for including an adequate representation of older adults in cancer clinical trials
Biologics
An 8/5-8/16/19 inspection at Reproductive Technologies, Berkeley, CA, found significant deviations from regulations for human cells, tissues, and cellular and tissue-based products. A just-released 11/6/19 Warning Letter says specific deviations were: * failing to quarantine semen from anonymous donors until the required retesting;
FDA Policy/General
Federal Register notice: FDA is withdrawing its 2006 guidance entitled “Exocrine Pancreatic Insufficiency Drug Products — Submitting NDAs.” Under the Biologics Price Competition and Innovation Act of 2009, FDA no longer can accept NDAs for such products and instead sponsors must submit BLAs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for Neurocrine Biosciences’ Ingrezza (valbenazine tosylate) indicated for treating adults with tardive dyskinesia. The review period is 2,071 days, which includes 1,827 days that occurred during the testing phase and 244 days during the
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “The ‘Deemed To Be a License’ Provision of the BPCI Act: Questions and Answers.” The document provides answers to common questions about FDA’s implementation of the statutory provision under which an application for a biological product approved under the