Drugs
FDA has published a draft guidance, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process, to assist applicants and drug master file holders to start either revisions to an existing monograph(s) or development of a new monograph(s) during the agency’s evaluation of a
FDA Policy/General
Federal Register final rule; technical amendments: FDA has issued a final rule to revise the animal drug regulations for new animal drug residue tolerances. The rule is necessary to standardize, simplify, and clarify the determination standards of tolerances and provide definitions for key terms. It is also intended to enhance
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Risk Evaluation and Mitigation Strategies: Modifications and Revisions.” The document provides information on how FDA will define and process submissions for modifications and revisions of risk evaluation and mitigation strategies (REMS), as well as information on what types of changes
Devices
FDA has posted a final guidance entitled “Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials.” The document is intended to provide factors to consider when evaluating the appropriateness of a live case presentation within a clinical investigation conducted under an IDE. It provides information about a live case
Drugs
Medical Research Collaborative is petitioning FDA to have an Amarin Corp. patent removed from the Orange Book for being improperly listed. The 7/8 petition says the Amarin patent for highly purified ethyl EPA and other EPA derivatives “does not claim an approved method of using the drug, promotes unapproved
Biologics
FDA has accepted for review a Sanofi BLA for isatuximab for treating patients with relapsed/refractory multiple myeloma. The investigational monoclonal antibody is designed to target a specific epitope on the CD38 receptor of a plasma cell. The agency has set a user fee review target action date of 4/
Devices
FDA has cleared a Centerline Biomedical 510(k) for the Intra-Operative Positioning System. The non-radiation-based surgical navigation system “leverages anatomical mapping algorithms and electromagnetic tracking technology to provide three-dimensional color visualization and guidance in real time during endovascular procedures,” the company says. It was developed at
FDA Policy/General
Healthcare media firm CMI/Compas says drug companies can effectively use Facebook health support groups as part of its social media promotion efforts. Writing in an online blog post, the company says “it’s no longer a question if Pharma should be engaged on social (media), but a question of
Drugs
Reacting to a federal judge’s ruling that HHS lacks statutory authority to require publication of drug list prices in certain direct-to-consumer drug ads, Senate Finance Committee chairman Chuck Grassley (R-IA) says he and Sen. Dick Durbin (D-IL) will continue to fight to have the prices
Drugs
The HHS Office of Inspector General (OIG) says progress has been made in decreasing opioid use in Medicare Part D and increasing use of medication-assisted treatment for opioid use disorder. The OIG report says it is “imperative for HHS, including the Centers for Medicare and Medicaid Services, to continue
Drugs
U.S. WorldMeds, which holds an NDA for Apokyn (apomorphine hydrochloride injection) indicated for acute, intermittent treatment of some aspects of Parkinson’s disease, says FDA should require that any ANDA for a generic version of Apokyn seek approval of both its drug and device constituent parts. The company says
Devices
FDA has cleared a Biotronik 510(k) for the Biomonitor III injectable cardiac monitor. The device is designed to document suspected arrhythmia or unexplained syncope with increased clarity, enabling fast diagnosis and appropriate treatment, the company says. Biomonitor III is 60% smaller than its predecessor and comes “pre-loaded in
Drugs
Four K&L Gates attorneys dissect two Justice Department policy statements and their impact on healthcare companies and their law firms in an online blog post. The attorneys first examine a 1/2018 memo issued by Civil Fraud Division director Michael Granston to determine what has happened over the
Drugs
FDA has released the FDA-483 issued following a 6/13-6/21 inspection at the Dr. Reddy’s drug manufacturing facility in Andhra Pradesh, India. Specific inspection observations were: * failing to establish acceptance activities prior to performance of validation activities; and * failing to correctly translate device design into production
Devices
A 4/3-4/4 FDA inspection at Clinicon Corp., Oceanside, CA, found Quality System Regulation violations in the firm’s work as a manufacturer (specification developer) of the SureProbe Class 2 sterile, single-use, laser accessory probes, among other devices. A 6/20 Warning Letter says specific violations were:
Drugs
A CDER Manual of Policies and Procedures gives the policies and procedures for staff in the Office of New Drugs, Office of Generic Drugs, and other CDER offices when implementing the law on requirements for safety labeling changes for approved drugs under the FDA Amendments Act of 2007 (FDAAA). The
Drugs
The Tufts Center for the Study of Drug Development says rare disease drug development is one of the most active and fastest growing areas in drug research and development, with nearly one-third of all products in the global R&D pipeline targeting treatments for rare disease indications. But
Drugs
A 10/31-12/18/18 FDA inspection at U.S. Pharmaceuticals, Belleville, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 6/6 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 11 NDAs from multiple applicants because the products are no longer marketed and the NDA holders requested that their approval be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of DHL Laboratories’ NDA for dextrose 5% injection in plastic containers, 5 g/100 mL, because the company has repeatedly failed to file required annual reports for the NDA. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available an immediately in effect guidance entitled “Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency.” The document describes FDA’s policy concerning the conditions under which the agency does not generally intend to take
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 31 Apotex ANDAs after the company requested that they be withdrawn due to FDA inspection concerns. After the drugs were approved, FDA says it became aware of concerns involving material manufactured at two Apotex facilities, at least one of which was named