FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Endorecherche’s Intrarosa (prasterone), indicated for treating moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. The regulatory review period is 3,381 days, which includes 2,983 days that
FDA Policy/General
Federal Register notice: FDA has announced a 3/10 public meeting entitled “Patient-Focused Drug Development for Stimulant Use Disorder.” The meeting seeks to obtain stakeholder perspectives on stimulant use disorder impacts and views on treatment approaches. To view the notice, click here.
FDA Policy/General
Comments Extended on Combo Product Bridging Guide Federal Register notice: FDA extends until 4/20 the comment period for a 12/2019 draft guidance on Bridging for Drug-Device and Biologic-Device Combination Products. 02/14/2020 28 ‘No Longer Marketed’ ANDAs Withdrawn Federal Register notice: FDA withdraws approval of
FDA Policy/General
Boehringer Ingelheim has launched opnME.com, a new platform offering free and open access to selected pre-clinical molecules for non-clinical investigation to scientists worldwide. The company says the platform contains molecules for some of the most relevant targets in biomedical research, and they are being shared to foster
FDA Policy/General
DEVICES FDA has cleared a 4WEB Medical 510(k) for its Lateral Spine Truss System, a 3D-printed lateral interbody fusion device. “4WEB’s proprietary truss implant technology leverages fundamental engineering principles in structural mechanics to address important clinical issues such as implant subsidence after lateral access surgery,” a news
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of 28 ANDAs from multiple applicants. The applicants notified the agency that the products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has extended until 4/20 the comment period for a 12/2019 draft guidance on Bridging for Drug-Device and Biologic-Device Combination Products. The guidance seeks to clarify how to bridge the information gathered from another development program to leverage that information in support of
FDA Policy/General
As part of its efforts to understand recent lung injuries associated with certain vaping products, FDA has opened a docket to obtain data and information on such injuries to help identify and evaluate additional steps the agency could take. The agency says it is seeking “unpublished data or information related
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Peripheral Vascular Atherectomy Devices — Premarket Notification Submissions.” The document provides recommendations for premarket submissions for a new or modified device. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has requested that industry organizations interested in participating in selecting nonvoting industry representatives to serve as temporary nonvoting members on CDRH’s Patient Engagement Advisory Committee notify it in writing. Nominees recommended to serve as a temporary nonvoting industry representative may either be self-nominated or
FDA Policy/General
In a 430-page budget justification for Congress, FDA commissioner Stephen Hahn says the agency’s request for $6.2 billion, an overall increase of $265.4 million compared to the FY 2020 enacted level (4.5% increase) will allow the agency to “invest in initiatives focused on the most
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “FDA Rapid Response Surveys” (OMB Control Number 0910-0500). The collection covers rapid response surveys for community-based healthcare professionals, general medical facilities, specialized medical facilities (those known for cardiac surgery, obstetrics/gynecology services, pediatric services, etc.
FDA Policy/General
Federal Register notice: FDA has announced a 3/30 public meeting entitled “Patient-Focused Drug Development for Vitiligo.” The meeting is intended for FDA to obtain patient perspectives on the impact of vitiligo on daily life, patient views on treatment approaches, and decision factors considered when selecting a treatment. To
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Electronic Submission Process for Voluntary Allegations to the Center for Devices and Radiological Health” (OMB Control Number 0910-0769). The collection involves information voluntarily submitted to CDRH on actual or potential health risk concerns about a medical device
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension on “Testing Communications on Medical Devices and Radiation-Emitting Products” (OMB Control Number 0910-0678). The agency conducts educational and public information programs related to medical device and radiation-emitting product safety. FDA says improving communications about devices
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection entitled “Generic Clearance for Qualitative Data To Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed.” To view the notice, click here.
FDA Policy/General
President Trump has proposed a relatively flat (1.6% increase) $6.2 billion budget for FDA’s fiscal year 2021 budget, which includes $3.3 billion for budget authority and $2.9 billion in user fees. The only medical product program area seeing any increase (5%) is medical devices with
FDA Policy/General
A new FDA literature review on cell phone radiofrequency radiation (RFR) exposure on human health has found “no quantifiable adverse health effects in humans caused by exposures at or under the current cell phone exposure limits.” The review looked at peer-reviewed in vivo and epidemiological studies published from 2008
FDA Policy/General
2 Guides on Drug Interaction Studies Federal Register notice: FDA releases two final guidances on drug interaction studies. 02/7/2020 Priority Review Voucher for Vyondys 53 Approval Federal Register notice: FDA issues a priority review voucher for the approval of a rare pediatric disease product application — Sarepta Therapeutics’ Vyondys
FDA Policy/General
Aptevo Therapeutics, a biotechnology company focused on developing novel immuno-oncology and hematology therapeutics, has completed the sale of three of its marketed products (WinRho SDF, HepaGam B, and Varizig) to Saol Therapeutics for $74.5 million. Mallinckrodt has acquired InfaCare Pharmaceutical Corp., a privately held specialty pharmaceutical company focused
FDA Policy/General
Federal Register notice: FDA has classified human immunodeficiency virus (HIV) drug resistance genotyping assays using next generation sequencing (NGS) technology into Class 2 (special controls). The action is in response to a 3/19 de novo classification request by Vela Diagnostics USA for its Sentosa SQ HIV Genotyping Assay. The
FDA Policy/General
Federal Register notice: FDA has announced a draft guidance entitled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.” The document provides recommendations on submitting a BLA supplement to add a condition of use that previously has been licensed