Author: estoddert

Public Workshop – Artificial Intelligence in Radiological Imaging

The U.S. Food and Drug Administration (FDA) announced a public workshop entitled “Evolving Role of Artificial Intelligence in Radiological Imaging,” will be held February 25-26, 2020. This workshop is an opportunity for stakeholders to provide feedback to the FDA on the following topics: Emerging applications of Artificial Intelligence (AI) in radiological imaging, including devices intended […]

FDA CDER Meetings, Conferences, and Workshops: December 2019

Public Meeting on CDER Standard Core Sets Clinical Outcome Assessments and Endpoints Grant Program; Dec. 5; Silver Spring MD; Live webcast available Repurposing Off-Patent Drugs: Research & Regulatory Challenges; Dec. 5-6; Rockville MD Public Workshop on Patient-Focused Drug Development: Guidance 4 – Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making; Dec. 6; Silver […]

FDA Draft Guidance: Adaptive Designs for Clinical Trials of Drugs and Biologics

On November 29, the Food and Drug Administration (FDA) issued a final guidance for industry entitled, “Adaptive Designs for Clinical Trials of Drugs and Biologics.” Adaptive design clinical trials allow for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. The guidance provides information to sponsors […]

FDA Draft Guidance: Providing Regulatory Submissions in Electronic Format: IND Safety Reports

The FDA just issued draft guidance for industry entitled Providing Regulatory Submissions in Electronic Format: IND Safety Reports and associated technical specifications documents. The FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research intends to implement a digital framework for the electronic submission, review, and tracking of certain investigational new drug (IND) safety […]

Oct. 29: FDA Webinar: Collaborative Communities

Date: October 29, 2019 Time: 03:00 PM – 04:30 PM EDT (To ensure you are connected, please dial in 15 minutes prior to the start of the webinar.) Registration is not necessary. Establishing collaborative communities is one of the Center for Devices and Radiological Health’s (CDRH’s) three strategic priorities for 2018-2020. CDRH envisions collaborative communities as […]

Posted FDA Guidance Documents

10/24/2019 – Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry This guidance provides information on the implementation of section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(o)(3)), which authorizes FDA to require certain postmarketing studies and clinical trials […]

New from CDRH

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 24, 2019. To view listings for other dates, see CDRH New – News and Updates. Federal Register: Orthopedic Devices; Classification of Orthopedic Surgical Instrumentation Designed for Osteochondral Implants with Press-Fit Fixation Federal Register: Physical Medicine Therapeutic Devices; Classification of the Internal Therapeutic […]

FDA Webinar: Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions

On October 16, 2019, the U.S. Food and Drug Administration (FDA) hosted a webinar to share information and answer questions about the final guidance, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions. This guidance outlines a rigorous, methodical approach for the consideration of uncertainty […]

Replies to Inquiries to FDA on Good Clinical Practice

GCP inquiries submitted by the public to the FDA’s Good Clinical Practice Program’s gcp.questions@fda.hhs.gov e-mail account are now available online. FDA on GCP Link: https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/replies-inquiries-fda-good-clinical-practice Visit this FDA page to search through years of answers to GCP related questions on: Adverse Events Inquiries Computer Questions Device Study Inquiries FDA Forms 1571 and 1572 Financial Disclosure Inquiries Foreign […]

FDA CDER Meetings, Conferences, and Workshops: October-November 2019

October 2019 PQRI BTC 2019 Webinar Series: Holistic QbD to Enable Product Quality; Oct. 10 @ 10:30 am EDT SBIA Webinar: Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards; Oct.11 @ 1 pm EDT Antimicrobial Drugs Advisory Committee Meeting; Oct 16; Silver […]

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