Drugs
FDA reviewers are backing a Sandoz BLA (GP2015) for a biosimilar copy of Amgen’s Enbrel (etanercept) for treating arthritis. The agency’s Arthritis Drugs Advisory Committee is meeting 7/13 to review and vote on the submission. “In considering the totality of the evidence submitted, the data submitted by
Drugs
Collegium Pharmaceutical has petitioned FDA for a block on other extended-release oxycodone drug products unless they bear abuse-deterrent labeling based on premarket studies. Earlier this year, the agency approved the company’s NDA for Xtampza ER (oxycodone) extended-release capsules with abuse-deterrent labeling based on premarket studies
FDA Policy/General
Federal Register Notice: FDA is issuing an Emergency Use Authorization for an in vitro diagnostic device for detecting the Ebola Zaire virus in response to the Ebola virus outbreak in West Africa. FDA issued this authorization under the Federal Food, Drug, and Cosmetic Act, as requested by Biocartis NV. To
FDA Policy/General
Federal Register Notice of availability: FDA is making available a guidance entitled Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Device. It describes the types of information that should be provided to support a claim of EMC in a premarket submission for an electrically powered
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act. For a drug product compounded by an outsourcing facility to qualify for the exemptions under
FDA Policy/General
Federal Register Notice: FDA is announcing the availability of a draft guidance for industry entitled Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act. To qualify for exemptions under section 503A of the FD&
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn. It describes a process for updating labeling for ANDAs in cases where FDA has withdrawn approval of the NDA for the ANDA’
FDA Policy/General
Federal Register Notice: FDA will co-sponsor a public workshop 9/30 entitled “Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices.” Its purpose is to discuss the increasing prevalence of myopia, as well as suggested clinical trial design attributes for studies using contact lenses or other medical
Drugs
FDA has issued two draft guidances describing its plans to implement legal provisions that restrict compounding human drug products that are essentially copies of commercially available or approved drug products. The guidances apply to pharmacies, doctors, federal facilities, and outsourcing facilities. An agency statement reasserts longstanding policy, saying that taking
Devices
Newark, NJ-based Pharmaceutical Innovations has pleaded guilty to criminal charges and resolved a civil lawsuit surrounding its distribution of ultrasound gel contaminated with bacteria. The company pleaded guilty in Newark federal court to an information charging it with two misdemeanor counts of introducing adulterated medical devices into interstate commerce,
Devices
FDA has issued a guidance, Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices, to describe relevant information that should be provided in a premarket submission to support a claim of electromagnetic compatibility (EMC) for an electrically-powered medical device. The document says that electrically-
FDA Policy/General
Federal Register Notice: FDA is issuing an Emergency Use Authorization for a Hologic Inc. in vitro diagnostic device for detecting the Zika virus in response to the Zika outbreak in the Americas. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics. It describes how publicly accessible databases of human genetic variants can serve as sources of valid scientific evidence to
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases. As part of the White House’s Precision Medicine Initiative, FDA is providing its proposed approach on
FDA Policy/General
Federal Register Notice: FDA will hold a public workshop 8/22-23 entitled: “Regional Public Workshop on ICH Q3D Implementation of Guideline for Elemental Impurities.” Its purpose is to elaborate key aspects of the ICH Guideline Q3D: Guideline on Elemental Impurities in order facilitate a harmonized interpretation and implementation by
FDA Policy/General
Federal Register Notice: FDA is publishing a list of information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995. These lists include information on MDUFMA Small Business Qualification Certification, Hearing, Aging, and Direct-to-Consumer Television Advertisements, and Electronic Submission
FDA Policy/General
Federal Register Notice: FDA is seeking public comment on the collection of information relating to general licensing provisions for BLAs, changes to an approved application, labeling, revocation and suspension, postmarketing studies status reports, and Form FDA 356h. This form is the “Application to Market a New Drug, Biologic, or an
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Current Good Manufacturing Practice for Positron Emission Tomography Drugs,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is seeking comments on its information collection associated with medical devices third-party review under the Food and Drug Administration Modernization Act. Comments should be submitted by 9/6. To view this notice, click here.
FDA Policy/General
Federal Register Final order: FDA is classifying the thermal system for insomnia into Class 2 (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the thermal system for insomnia's classification. To view
FDA Policy/General
Recently FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Guangzhou Haishi Biological Technology Co., Ltd. Guangzhou, Guangdong China (6/22). Inspected 7/20-24/15. GMP deviations, adulterated: The firm failed to test finished batches of the firm’
FDA Policy/General
Federal Register Notice: FDA is making available a guidance: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Guidance for Industry. It provides investigational new drug application (IND) sponsors with recommendations on IND submissions for early clinical trials with live biotherapeutic products in the U.S. The