FDA Policy/General
Federal Register Notice: FDA’s Center for Tobacco Products is inviting participation in its Tobacco Product Manufacturing Facility Visits. The program is intended to give FDA staff an opportunity to visit facilities involved in the manufacturing of newly deemed tobacco products and their components and parts, including any related laboratory
FDA Policy/General
The Government Accountability Office (GAO) says that FDA lacks measurable goals with which to assess its progress in advancing regulatory science. “The agency issued strategic planning documents in 2011 and 2013 to guide its regulatory science efforts and identify priority areas for conducting work,” the GAO says in a new
FDA Policy/General
Federal Register Notice: FDA is releasing “Modifications to the List of Recognized Standards, Recognition List Number: 042,” a publication containing modifications it is making to the list of standards that it recognizes for use in premarket device review. It will assist manufacturers who elect to declare conformity with consensus standards
FDA Policy/General
Federal Register Final rule: FDA is revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as “stand-alone symbols”) if certain requirements
Devices
FDA clears a Tyber Medical 510(k) for its headed and snap-off screw systems, indicated for use throughout the extremities in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair and fracture fixation appropriate for the size of the device. The cannulated headed screws (available in 1.5mm-9.0mm)
Devices
FDA has issued a draft guidance, Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions, to clarify for industry and agency staff the benefit and risk factors FDA may consider in prioritizing resources for compliance and enforcement efforts to maximize medical device quality and
Devices
Two new warnings are included among revisions Boston Scientific has made to the directions for use for six stress urinary incontinence products. A company announcement says that the first warning states that mesh is considered a permanent implant and removal of mesh or correction of mesh-related complications may involve
Devices
FDA has accepted an Allergan 510(k) for the XEN Glaucoma Treatment System (comprising the XEN45 Gel Stent and the XEN Injector). The implantable crosslinked gelatin shunt is intended for use to reduce intraocular pressure associated with refractory glaucoma, according to the company. The device is CE marked in the
Devices
FDA has posted a guidance on “Use of International Standard ISO 10993-1 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.” The agency says the document is intended to assist industry in preparing marketing submissions for medical devices that come into direct or
Drugs
Former FDA Office of Generic Drugs deputy director and now consultant Gordon Johnston has pled guilty and admitted his role in an insider trading scheme that obtained highly confidential and material nonpublic information from a senior FDA official about the status and impending approval of generic enoxaparin (Sanofi-aventis’ blockbuster
FDA Policy/General
The FDA strategic integrated management plan (SIMP) for its three Centers overseeing medical products (CBER, CDER, CDRH) does not include leading practices for strategic planning or document a comprehensive strategy for the Centers, according to a new Government Accountability Office report. In 2012, Congress required the agency to develop a
Biologics
Six groups representing biologic prescribers have sent a letter to the Senate Health, Education, Labor and Pensions (HELP) Committee leadership commending the bipartisan sponsorship of Section 11 of S. 2700, a provision of the 21st Century Cures Act, that assures full FDA authority over the identity (name) and quality standards
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Austin Biotechnology Inc. Taipei, Taiwan (6/2). Inspected 5/28-29/15. GMP deviations, adulterated: The firm failed to establish a quality control unit with the responsibility and authority
Biologics
FDA has issued a final rule to explicitly allow for optional inclusion of standalone symbols without adjacent explanatory text in labeling for medical devices and certain biological products if certain conditions are met. The rule also specifies that using symbols, accompanied by adjacent explanatory text, continues to be permitted. The
Drugs
FDA says that its review of several Web sites owned by Focus Laboratories, North Little Rock, AR, indicates that the company is marketing items that the agency has determined are unapproved new drugs and are misbranded. A 6/3 Warning Letter from the agency’s Dallas District Office refers to
FDA Policy/General
FDA assistant commissioner for minority health Jonca Bull says the agency is launching a campaign to encourage minorities to participate in clinical trials for all medical conditions. Writing in an FDA Voice blog post, Bull says the campaign will launch 6/19, World Sickle Cell Day, to “encourage diverse communities
Drugs
Three Fish & Richardson attorneys say that Janssen’s Massachusetts federal court suit against Celltrion is of interest because it is one of the few currently pending litigations related to biosimilars and the Biologics Price Competition and Innovation Act (BPCIA). Writing in an online blog post, the attorneys says that
Drugs
A 5/28-29/15 FDA inspection at Austin Biotechnology, Taipei, Taiwan, found significant violations of current good manufacturing practice for finished pharmaceuticals, according to a 6/2 Warning Letter. Specific violations cited in the letter included: * failing to establish a quality control unit with the responsibility and authority to
FDA Policy/General
FDA says it is working with the Clinical Trials Transformation Initiative (CTTI) to create a new work group with patient advocacy organizations to talk about patient engagement at the agency. An FDA notice says that the agency will leverage CTTI’s strengths in multi-stakeholder engagement to coordinate the new
Drugs
FDA has denied, without comment on whether it will take the requested action, a United Therapeutics 1/15 petition asking that the agency not approve any ANDA for a treprostinil inhalation solution drug-device combination product referencing Tyvaso unless certain conditions are met. The petition said the ANDA should: * request
Drugs
Marathon Pharmaceuticals has submitted an NDA for the investigational drug deflazacort for treating patients with Duchenne muscular dystrophy (DMD), the most common and most severe form of muscular dystrophy. The submission is supported by preclinical and clinical study data, including two pivotal clinical efficacy trials exclusively licensed by Marathon in
Devices
FDA has approved an Aspire Bariatrics PMA for the AspireAssist, a new obesity treatment device that uses a surgically-placed tube to drain stomach contents after every meal. “The AspireAssist device should not be used on patients with eating disorders, and it is not intended to be used for short