Drugs
FDA commissioner Robert Califf and associate deputy commissioner for medical products and tobacco Rachel Sherman say that FDA is involved in developing a national system for evidence generation that can improve the ways in which scientific evidence to support medical product evaluation and clinical care decisions is generated. Writing in
Drugs
CDER deputy director for science operations Richard Moscicki says that FDA’s breakthrough therapy designation for new drugs often is misinterpreted by the media or consumers to mean that the drug has already been conclusively shown to be a major game-changing advance. “What I’d like the public to
Drugs
Heron Therapeutics says it has begun labeling discussions with FDA over an NDA resubmission for its Sustol (granisetron) extended release injection, indicated for preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens. The original user fee goal
Devices
FDA has cleared a Toshiba America Medical Systems 510(k) for its Aquilion Lightning CT system. The 16-detector row system is designed for routine volumetric scanning. It has a small footprint to allow providers to save on both space and cost, according to the company. It offers the company’
Drugs
FDA has sent Chiasma, Inc. a complete response letter (CRL) on its NDA for Mycapssa (octreotide) capsules for the maintenance treatment of adult patients with acromegaly. Upon completing its review, the agency told the company that the submission had not provided substantial evidence of efficacy to warrant approval and that
FDA Policy/General
Federal Register Notice: FDA’s Center for Tobacco Products is inviting participants for its voluntary Tobacco Farm Site Tours Program. This program is intended to give staff an opportunity to visit farms that grow tobacco for sale to tobacco product manufacturers in order to gain a better understanding of tobacco
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Section 503B defines an outsourcing facility, in part, as “a facility at one geographic location or address.” FDA has received questions from outsourcing facilities
FDA Policy/General
Federal Register Notice: FDA will hold a public meeting 6/10 and is making an opportunity for public comment on Patient-Focused Drug Development for neuropathic pain associated with peripheral neuropathies. The public meeting is intended to allow FDA to obtain patient perspectives on the impact of neuropathic pain associated
FDA Policy/General
Federal Register Notice: FDA is announcing a regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting will take place on the FDA campus and also be broadcast
FDA Policy/General
Federal Register Notice: FDA is withdrawing approval of two AbbVie NDAs for Advicor (niacin extended-release and lovastatin) tablets and Simcor (niacin ER and simvastatin) tablets. The company has requested the withdrawal and has waived its opportunity for a hearing. The agency has also determined that Advicor and Simcor were
FDA Policy/General
Federal Register Final order: FDA is issuing a final order to reclassify external pacemaker pulse generator (EPPG) devices, which are currently preamendments Class 3 devices (regulated under product code DTE), into Class 2 (special controls) and to reclassify pacing system analyzers (PSAs) into Class 2 based on new information and
FDA Policy/General
Federal Register Final rule: FDA is amending the animal drug regulations to reflect application-related actions for NADAs and ANADAs during January and February. The agency is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal
Biologics
Emergent BioSolutions has submitted a supplemental BLA seeking approval for manufacturing BioThrax (anthrax vaccine adsorbed) at the company’s large-scale manufacturing facility (Building 55). The submission is supported by data that demonstrate that BioThrax manufactured in Building 55 is comparable to BioThrax manufactured in the currently-licensed facility, according
Drugs
FDA’s Nonprescription Drugs Advisory Committee has unanimously (12 to 0) voted to support approval for a Galderma Labs application seeking over-the-counter marketing of Differin (adapalene gel 0.1%) for treating acne in consumers ages 12 years and older. Some panel members said that a proposed Drug Facts
Drugs
Hospira has recalled one lot of 50% magnesium sulfate injection, USP, 10 g/20 mL (0.5 g/ml), 20 mL single-dose vials (Lot 50-343-DK, Expiration 2/1/2017, NDC 0409-2168-02) due to a confirmed customer complaint involving particulate matter present in one vial. A
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002,” 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,
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act. It describes how FDA intends to apply the FD&C Act to drugs compounded by licensed pharmacists or physicians in state-licensed hospital
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance for industry entitled Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act. It describes the agency’s policy on certain prescription requirements for compounding human drug products for identified individual patients under section FDCA 503A. It
FDA Policy/General
Federal Register Notice: FDA is making available a guidance entitled Radiation Biodosimetry Medical Countermeasure Devices. It has been developed to provide industry and agency staff with recommendations for the types of information that should be submitted to support marketing authorization for radiation biodosimetry medical countermeasure devices. To download this guidance,
FDA Policy/General
Federal Register Notice: FDA is withdrawing approval of the indications related to the co-administration with a statin for niacin extended-release tablets and fenofibric acid delayed-release capsules. Affected applications include one NDA and seven ANDAs for niacin ER tablets, and one NDA and three ANDAs for fenofibric acid
FDA Policy/General
Federal Register Proposed rule: FDA is reopening the comment period for the proposed rule, published in the 12/23/15 Federal Register revising its regulations on prescription and nonprescription fixed-combination and co-packaged drugs and on combinations of active ingredients under consideration for inclusion in an over-the-counter
FDA Policy/General
BIOLOGICS Review Period Set for Gazya Federal Register Notice: FDA has determined the regulatory review period for Genentech’s Gazya is 1,698 for extending a patent which claims the human biological product. Gazyva is indicated, in addition with chlorambucil, for treating patients with previously untreated chronic lymphocytic leukemia. To