FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Inspire’s Upper Airway Stimulation System is 2,002 days, and of this time, 1,653 days occurred during the testing phase and 349 days occurred during the approval phase. The product is indicated
FDA Policy/General
Federal Register notice: FDA has announced an extension of the deadline to provide Logical Observation Identifiers Names and Codes for clinical laboratory test results in investigational study data provided in regulatory submissions submitted to CDER and CBER. FDA has determined, in response to industry comments and internal review, that it
FDA Policy/General
Federal Register notice: FDA has classified devices that detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class 2 (special controls). This action is in response to a 4/2015 BioFire Diagnostics request for de novo classification of its FilmArray Meningitis/Encephalitis Panel. The agency has named the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance for industry on generic tiotropium bromide inhalation powder. The document, when finalized, will provide product-specific recommendations on the design of bioequivalence studies to support ANDAs for such products. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available three draft guidances for industry on generic salmeterol xinafoate inhalation powder, fluticasone propionate inhalation aerosol, and fluticasone propionate inhalation powder. The documents, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence studies to support ANDAs for such
FDA Policy/General
Federal Register notice: CDRH has announced its 2018 Experiential Learning Program. The training is intended to provide the Center and other FDA staff with an opportunity to understand laboratory practices, quality system management, patient perspective/input, and challenges that impact the medical device development life cycle. This notice invites the
FDA Policy/General
Federal Register notice: FDA has classified the organophosphate test system into Class 2 (special controls). The agency action is the result of a 2013 de novo petition from the Centers for Disease Control and Prevention for its Quantitation of Organophosphate Metabolites in Urine by LC/MS/MS. The agency has
FDA Policy/General
Healthcare media resource CMI says that Google “bumper ads” placed before YouTube videos “can go a long way for brand recall if executed strategically.” The six-second videos that can’t be stopped early drove 30% higher ad recall than in-stream ads, according to Google statistics cited by CMI
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension request for “Medical Devices; Device Tracking — 21 CFR Part 821.” FDA is given discretion in applying tracking provisions to medical devices meeting certain criteria and provides that tracking requirements for medical devices can be imposed only after it
FDA Policy/General
Federal Register notice: FDA has classified nucleic acid-based devices for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens into Class 2 (special controls). The classification requested was submitted in a 5/2014 de novo petition from T2 Biosystems for the T2Candida Panel and T2Dx
FDA Policy/General
Federal Register notice: FDA has classified automated image assessment systems for microbial colonies on solid culture media into Class 2 (special controls). The action is the result of a 12/2015 de novo petition from Clever Culture Systems AG for its APAS Compact. The agency has named the generic type
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Diasol, Inc. San Fernando, CA (9/25): FDA inspected the firm in June and cited GMP deviations with liquid and powder dialysate concentrate products and liquid and powder sodium
Drugs
Three Gibson, Dunn & Crutcher attorneys write in a WLF Legal Pulse published by Washington Legal Foundation that a Federal Trade Commission (FTC) suit against Shire is the latest development in the FTC’s well-established program for enforcing antitrust laws where it feels generic competition is being blocked or
FDA Policy/General
Federal Register notice: FDA has classified enzyme packed cartridges into Class 2 (special controls). The action is the result of a 1/2015 de novo submission from Alcresta, Inc. for Relizorb. The agency has named the generic type of device “enzyme packed cartridge,” and it is identified as an ex
FDA Policy/General
Federal Register notice: FDA is correcting a 9/21 Federal Register notice that announced the withdrawal of approval of 27 abbreviated new drug applications (ANDAs) from multiple applicants. The document was published with the incorrect docket number. The correct docket number is: FDA – 2017 – N – 5226. To view the notice,
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Post-Complete Letter Meetings Between FDA and ANDA Applicants Under GDUFA.” The document is intended to clarify the criteria for granting post-complete response letter meeting requests and the scope of discussions for granted meeting requests. To view the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Medical Devices; Humanitarian Use Devices (HUDs) — 21 CFR 814.” Under FDA regulations, the agency is authorized to exempt a HUD from effectiveness requirements provided that the device: (1) Is designed to treat or diagnose a disease or
FDA Policy/General
Federal Register notice: FDA has sent to OMB an information collection extension request for a guidance on “Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” The document discusses options facilities have in deciding whether to register with FDA as an
FDA Policy/General
Federal Register notice: FDA has sent to OMB an information collection extension request for a guidance on “Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act.” The guidance was mandated by the 2013 Drug Quality and Security Act that established drug
FDA Policy/General
A California dietary supplement manufacturer, Custompax Inc. (Freemont, CA) and its CEO Cedric Ling have been ordered to stop selling their products until they come into compliance with FDA dietary supplement manufacturing regulations and other requirements listed in a consent decree. According to the government, Custompax manufactured and sold customized
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” The document is intended to assist applicants in determining which one of the abbreviated approval pathways is appropriate for submitting a marketing application to the agency. To
FDA Policy/General
Federal Register notice: FDA has announced a 12/12 Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meeting. Panel members will discuss, make recommendations, and vote on information regarding a Intrinsic Therapeutics PMA for the Barricaid Anular Closure Device, which is intended to be implanted following a