Drugs
FDA has updated its list identifying all drug products about which the agency has received a reference-listed drug (RLD) access inquiry. The list includes the name of the applicable RLD sponsor, the number of RLD access inquiries FDA has received about the product, and whether the agency has communicated
Drugs
House Speaker Nancy Pelosi (D-CA) has released her “transformative” drug pricing legislation and says she hopes the White House will support it. NPR reports that the proposal calls for HHS to annually negotiate prices for the top 250 most expensive drugs on the market that don’t have at
Drugs
FDA has granted Genentech a breakthrough therapy designation for Gazyva (obinutuzumab) for adults with lupus nephritis. This designation was based on data from the Phase 2 NOBILITY study in adult patients with proliferative lupus nephritis which showed Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and
Devices
FDA has granted Active Implants a breakthrough device designation for the NUsurface Meniscus Implant. The device is made from medical grade polymer and because of its composite structure and design, it does not require fixation to bone or soft tissues, the company says. It mimics the function of the natural
Devices
FDA has cleared a Viseon 510(k) for its Voyant System to integrate minimally invasive surgical access with real-time high definition imaging. The device is intended to assist a physician’s intraoperative visualization, providing a precise and unimpeded view of the operative field, the company says. It offers a
FDA Policy/General
FDA has released its long-awaited Technology Modernization Action Plan (TMAP) that describes short-term actions it is taking to modernize technology use — computer hardware, software, data, and analytics. The plan has three elements: (1) modernizing FDA’s technical infrastructure; (2) enhancing its capabilities to develop technology products to support
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) outlining the policies and procedures of the Office of Generic Drugs and Office of Pharmaceutical Quality for (1) evaluating requests from prospective ANDA applicants for a product development or pre-submission pre-ANDA meeting; and (2) conducting such meetings. Under
Drugs
FDA has finalized a guidance on “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.” The document provides information on FDA’s current thinking on interpreting Section 505(q) of the Food, Drug, and Cosmetic Act, which governs
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h” (OMB Control Number 0910-0338). The FDA Modernization Act amended agency regulations to require
Devices
FDA has issued a draft guidance, Safer Technologies Program for Medical Devices, introducing a new, voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with
Drugs
FDA has granted an orphan drug designation for its novel gene therapy (OCU400) for treating the CEP290 mutation-associated retinal disease. Inherited retinal diseases are caused by genetic mutations that are passed down within families and lead to visual impairment and blindness. Mutations in CEP290 have been associated with different
FDA Policy/General
Federal Register notice: FDA has announced it has revoked an emergency use authorization issued to Luminex for the xMAP MultiFLEX Zika RNA Assay. The in vitro diagnostic device for detecting the zika virus was revoked aat the company's request because the product will no longer be marketed. To
Devices
Attorney Vernessa Pollard (McDermott Will & Emery) says that companies that secure digital health software precertification from FDA “may have increased post-market surveillance and data collection obligations, with a particular emphasis on real-world data.” Writing in an Of Digital Interest online blog post, she says that increased post-
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.