Drugs
Rep G. K. Butterfield (D-NC) and the co-chairs of the Childhood Cancer Caucus, Reps. Michael McCaul (R-TX), Jackie Speier (D-CA) and Mike Kelly (R-PA) have introduced the Creating Hope Reauthorization Act. The measure would make permanent a priority review voucher program for pediatric rare disease
Devices
CDRH is seeking comments on its just-released “Health of Women Program Strategic Plan” that aims to “explore the unique issues related to the performance of medical devices in women, not only in the reproductive health space, but across a woman’s lifetime.” The plan focuses on three priority areas:
Drugs
FDA has made available a final guidance entitled “Wholesale Distributor Verification Requirement for Saleable Returned Drug Product — Compliance Policy.” The guidance announces a one-year delay in enforcement of a Drug Supply Chain Security Act (DSCSA) provision requiring wholesale distributors to verify a product identifier prior to further distributing returned
Drugs
FDA has issued a final guidance entitled Amyotrophic Lateral Sclerosis: Developing Drugs for Treatment. The document provides FDA’s current scientific thinking so that, it says, effective treatments with a favorable benefit to risk profile can be most efficiently developed, studied and ultimately made available to patients. It was developed
Devices
FDA has approved Medtronic’s Evolut Pro+ Transcatheter Aortic Valve Replacement (TAVR) System. The device includes four valve sizes with an external pericardial tissue wrap that provides what the company describes as “advanced sealing for the largest indicated patient treatment range and the lowest delivery profile currently on the market.
Drugs
Federal Register notice: FDA has made available a draft guidance entitled “Interacting with the FDA on Complex Innovative Clinical Trial Designs for Drugs and Biological Products.” The document provides recommendations and discusses using novel trial designs, how sponsors may obtain feedback on technical issues related to modeling and simulation, and
FDA Policy/General
Comments Sought on Developing CNS Stimulants Federal Register notice: FDA seeks comments on development and evaluation of abuse-deterrent formulations of central nervous system stimulants. 09/20/2019 Device Guidances Under Safety/Performance Pathway Federal Register notice: FDA makes available several device-specific draft guidance documents for the agency’ device
FDA Policy/General
DEVICES Instrumentation Laboratory has received FDA 510(k) clearance of its ACL TOP Family 50 Series Hemostasis Testing Systems for mid- to-high-volume clinical laboratories, including those using lab automation tracks. According to the company, the systems offer automated pre-analytical sample integrity checks which identify under-filled sample
Drugs
Darmerica has recalled two lots of quinacrine dihydrochloride bulk active pharmaceutical ingredient (API) due to a label mix-up. Quinacrine is used as an antiprotozoal, antirheumatic, intrapleural sclerosing agent. The lots were tested and identified as artemisinin API, which is used for treating malaria. “Receiving artemisinin rather than quinacrine could
FDA Policy/General
Federal Register notice: FDA is seeking comments on development and evaluation of abuse-deterrent formulations (ADFs) of central nervous system stimulants and whether such products could play a role in addressing public health concerns related to prescription stimulant misuse and abuse. The notice also provides an overview of available postmarket
FDA Policy/General
Federal Register notice: FDA has made available several device-specific draft guidance documents for the agency’s device Safety and Performance Based Pathway. They are: Spinal Plating Systems — Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff; Cutaneous Electrode for Recording
Devices
FDA has released a draft guidance entitled Pilot Accreditation Scheme for Conformity Assessment Program that outlines goals, scope, procedures, and a suitable framework for the voluntary pilot, which was mandated by the FDA Reauthorization Act of 2017. The program is intended to support the agency’s continued efforts to use
Drugs
FDA has approved Novo Nordisk’s Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with Type 2 diabetes, along with diet and exercise. The agency says this is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the U.S.
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