Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports FDA efforts to develop a benefit/risk framework for approving prescription opioid medicines that accounts for public health concerns. In its comment on an agency draft guidance, PhRMA proposes: * FDA revise the draft to state more clearly that under the
Drugs
Attorney James Beck (Reed Smith) says drug companies and their attorneys involved in failure-to-warn suits “should closely examine all allegations of ‘inadequate’ warnings to determine whether such claims would create inconsistencies with Highlights information [in the drug’s label], and adjust their preemption strategy accordingly.” Writing in a
Drugs
Legislation awaiting signature by California’s governor does not prohibit pay-for-delay settlements between branded and generic drug companies but presumes an anticompetitive effect if, as part of a Paragraph 4 litigation settlement, an ANDA sponsor receives anything of value in exchange for limiting or foregoing entry of a
Drugs
Pharmaceutical Manufacturing Research Services (PMRS) is asking the DC Court of Appeals to overturn an FDA decision refusing to approve its Roxicodone, a new opioid capsule the company says is intended to deter abuse through a novel combination of physical properties and labeling changes. The company says the Roxicodone label
Devices
FDA has cleared a Sofwave Medical 510(k) for its Sofwave system, indicated for use as an esthetic (XXX SPELLING XXX)treatment to improve facial lines and wrinkles. The company says the clearance was supported by a blinded study in 59 subjects. According to the investigators’ evaluation, 86% of the
Devices
FDA has granted Orchestra BioMed a breakthrough device designation for its Virtue Sirolimus-Eluting Balloon for treating below-the-knee peripheral artery disease. The device is designed to deliver sustained-release sirolimus during angioplasty without the need for coating or a permanent implant. “Angioplasty with plain balloons, which has been
Drugs
A 10/22-10/30/18 FDA inspection at SC Johnson Professional (formerly Deb USA), Stanley, NC, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and requirements for registration and listing of drug products. A just-released 6/11 Warning Letter says specific CGMP violations
Biologics
FDA has accepted for priority review a Merck BLA for its investigational Ebola vaccine (V920) for preventing disease caused by the Ebola Zaire virus. The agency has set a 3/14/2020 user fee review action target dated. In July 2016, FDA granted Breakthrough Therapy Designation to V920. While developing
Devices
FDA has cleared a Canon 510(k) for its Xephilio OCT-A1 Optical Coherence Tomography device for in-vivo imaging and measurement of the retina, retinal nerve fiber layer, and optic disc. In addition, it is intended to aid in the diagnosis and management of retinal diseases by a clinician.
Drugs
FDA says it has taken its first regulatory actions under Project Orbis, which provides a framework for concurrent submission and review of oncology drugs among its international partners. Under the project, FDA, the Australian Therapeutic Goods Administration and Health Canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous
FDA Policy/General
The Coalition for Healthcare Communication says five CDER Office of Prescription Drug Promotion research studies are completed and awaiting peer review and publication. Four of the studies look at aspects of direct-to-consumer (DTC) advertising. Coalition executive director Jon Bigelow says the studies “will make an important contribution to
Drugs
GlaxoSmithKline says that while it agrees with FDA’s need to have access to additional supportive files in population pharmacokinetics analyses, the current portal for submissions makes the process challenging. Its comment letter says that very few file types are supported and most of the file formats routinely used by
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Deb USA, Dallas, TX (6/11): FDA inspected the firm 10/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to establish adequate written
FDA Policy/General
Former FDA commissioner Scott Gottlieb has joined Aetion’s board of directors. The health care technology company is working to deliver real-world evidence (RWE) for life science companies, payers, and regulatory agencies. As a board member, Gottlieb will advise the company as it expands the reach and utility of
Drugs
The new FDA Knowledge-aided Assessment & Structured Application (KASA) system “will promote issued-based quality assessment using structured data and information to improve the efficiency, consistency, and objectivity of regulatory actions,” according to six CDER staffers writing in the International Journal of Pharmaceutics. The article says the agency recognized
Drugs
Takeda Pharmaceutical Co. has recalled all doses of Natpara (parathyroid hormone) for injection (25 mcg, 50 mcg, 75 mcg, and 100 mcg) due to a potential issue related to rubber particulates originating from the rubber septum of the product’s cartridge. During a typical 14-day Natpara treatment period, the
Devices
An FDA advisory committee has recommended that FDA should develop standards for device companies to use when communicating any cybersecurity concern to patients. The agency’s Patient Engagement Advisory Committee met 9/10 to discuss communicating to patients about cybersecurity risks. “Preserving the benefit of these devices requires continuous vigilance
FDA Policy/General
Federal Register notice: FDA has made available 53 product-specific guidances (PSGs) – 34 new guidances and 19 revised ones, including 16 PSGs for complex drug products. Five of the new drafts and 11 of the revised drafts are for complex drug products. Nearly half of these 53 PSGs (8 complex
Drugs
FDA has awarded three grants under a pilot program to support developing publicly available clinical outcome assessments (COAs) and related endpoints for specific disease indications (RFA-FD-19-006). “These awards will provide avenues to advance the use of patient input as an important part of drug development that can
FDA Policy/General
Federal Register notice: FDA has revoked an Emergency Use Authorization (EUA) issued to Siemens Healthcare Diagnostics for the Advia Centaur Zika test. The EUA was revoked because Siemens subsequently received clearance for the test under the 510(k) program. To view the notice, click here.
FDA Policy/General
FDA principal deputy commissioner Amy Abernathy tweeted 9/16 that within a month the agency will be rolling out a plan to modernize its information technology approach for its regulatory mission, including reviewing medical product applications. She previously has said this will include modernization of FDA infrastructure to make sure
Drugs
Janssen Pharmaceutical has submitted a supplemental BLA for Tremfya (guselkumab) for treating adult patients with active psoriatic arthritis. The human monoclonal antibody was approved originally 7/2017 for treating adult patients with moderate to severe plaque psoriasis. Janssen says the sBLA is based on results from the Phase 3 DISCOVER-