FDA Policy/General
Federal Register notice: FDA has announced a 10/29 Bone, Reproductive and Urologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss an Amag Pharmaceuticals supplemental NDA for Makena (hydroxyprogesterone caproate injection), 250mg/ml, for reducing the risk of preterm birth in women with a singleton pregnancy who have
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Amyotrophic Lateral Sclerosis (ALS): Developing Drugs for Treatment.” The document addresses the clinical development of drugs intended to treat the main motor aspects of ALS, i.e., muscle weakness and its direct consequences, including shortened life expectancy. It does
FDA Policy/General
Federal Register notice: FDA has made available a draft guide entitled “The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.” The program is authorized under the FDA Reauthorization Act of 2017 and the Medical Device User Fee Amendments of 2017. FDA believes the pilot may further encourage international harmonization of
FDA Policy/General
FDA has posted a draft Guidance for Industry (GFI) #263, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter,” to help explain the recommended process for voluntarily changing the approved
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Device Guidances Under Safety/Performance Pathway Federal Register notice: FDA makes available several device-specific draft guidance documents for the agency’ device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
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
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
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
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
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
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
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
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
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
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
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