FDA Policy/General
The Senate Appropriations Committee has approved an FY 2020 FDA appropriations bill (view details here and here), which includes $3.148 billion in discretionary funding for the agency — $80 million above the FY 2019 enacted level. The measure includes a $7 million increase for medical countermeasures initiatives, $10 million to
Drugs
FDA has approved package size and package type limits for over-the-counter (OTC) forms of loperamide, indicated for controlling symptoms of diarrhea. The changes are intended to address the problem of loperamide abuse and misuse (see earlier story) by limiting each carton to no more than 48 mg of
Devices
Former CDRH director John C. Villforth died 9/14 at the age of 88. Vilforth retired in 1990 after serving 29 years at the agency. He then served as Food and Drug Law Institute president from 1990-2001. Vilforth also helped lead the creation of the Food and Drug Administration
FDA Policy/General
FDA has issued a proposed rule setting requirements related to the content, format and review and communications procedures for premarket tobacco product applications (PMTAs) as part of its oversight of e-cigarettes and other tobacco products. This is part of the Trump Administration’s response to ongoing e-cigarette/vaping
Devices
FDA says it has issued four draft guidances and updated a final guidance relating to the Safety and Performance Based Pathway as part of its commitment to strengthening and modernizing the 510(k) program. The updated Safety and Performance Based Pathway guidance gives the agency’s current thinking on the
Drugs
FDA has established a public docket soliciting comments from patients, patient advocates, healthcare professionals, academics, researchers, the pharmaceutical industry and other government entities on considerations relating to the development and evaluation of abuse-deterrent formulations (ADF) of central nervous system stimulants. Comments are also sought on whether such products could
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Adverse Event Program for Medical Devices (Medical Product Safety Network (MedSun))” OMB Control Number 0910-0471. The agency’s regulations authorize it to require (1) manufacturers to report medical device-related deaths, serious injuries, and malfunctions; and
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Safer Technologies Program for Medical Devices,” which describes a new, voluntary program for certain devices and device-led combination products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
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.” The document provides FDA’s current thinking on what constitutes a 505(q) petition and describes some of
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-