Division of Clinical Research

Office of the Vice President and Innovation

Category results for: FDA Guidance

Recently Posted FDA Guidance Document: COVID-19 Convalescent Plasma

Investigational COVID-19 Convalescent Plasma: Guidance for Industry On August 23, 2020, FDA issued an Emergency Use Authorization (EUA)  for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19.  FDA has subsequently reissued this EUA with revisions.   FDA recognizes that while COVID-19 convalescent plasma may be used under an EUA consistent with the […]

FDA Guidance “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency”

On January 15, 2021, FDA published a new guidance for industry, Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency. FDA is issuing this guidance to assist prospective applicants of abbreviated new drug applications (ANDAs) in ensuring the protection of participants when resuming or initiating bioequivalence (BE) studies conducted […]

FDA Posted Guidance Documents

New FDA Posted Guidance Documents 1/6/2021 – Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Guidance for Industry and Food and Drug Administration Staff 1/6/2021 – Safer Technologies Program for Medical Devices: Guidance for Industry and Food and Drug Administration Staff 1/5/2021 – Mouse Embryo Assay for Assisted Reproduction Technology Devices 1/5/2021 – Human Gene […]

FDA Final Guidance: Safer Technologies Program for Medical Devices

The U.S. Food and Drug Administration (FDA) issued final guidance outlining the Safer Technologies Program (STeP) for Medical Devices. This program will be a voluntary pathway for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics for diseases or conditions that are less serious […]

FDA DRAFT GUIDANCE “IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators”

This guidance is intended for sponsor-investigators developing individualized investigational antisense oligonucleotide (ASO) drug products for a severely debilitating or life-threatening genetic disease. Most often, individuals with such diseases will not have FDA-approved treatment options and their diseases will be rapidly progressing, resulting in early death and/or devastating irreversible morbidity within a short time frame. In […]

FDA Publishes Final Guidance for Controlled Correspondence Related to Generic Drug Development

On December 16, 2020, FDA announced the availability of the final guidance for industry entitled “Controlled Correspondence Related to Generic Drug Development.” This final guidance provides information on the following: Process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development Agency communications related […]

Recently Posted FDA Guidance Documents

New FDA Guidance Documents   12/4/2020 – Requesting FDA Feedback on Combination Products: Guidance for Industry and FDA Staff 12/2/2020 – Recommendations for Screening, Testing, and Management of Blood Donors and Blood and Blood Components Based on Screening Tests for Syphilis: Guidance for Industry 12/1/2020 – Guidance for Industry: Enforcement Policy for Providing an Acceptable Unique Facility Identifier (UFI) […]

Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA

Join the CDER Small Business and Industry Assistance webinar Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA December 16, 2020 | 1:00 – 2:30 p.m. Eastern FREE Registration In this era of globalization, meeting various regulatory authorities’ expectations in recruitment of diverse trial population is challenging. The need for faster drug […]

FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development

The final guidance issued on November 9th, “Enhancing the Diversity of Clinical Trial Populations–Eligibility Criteria, Enrollment Practices, and Trial Designs,” was first issued as a draft in 2019. It provides the FDA’s current thinking on steps to broaden eligibility criteria in clinical trials through inclusive trial practices, trial designs, and methodological approaches. The guidance aims […]

FDA Issues Final Guidance on Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol

The FDA had issued this final guidance: Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol. Read the guidance The final guidance: Describes recommendations about what information industry should include in premarket submissions for medical devices containing nitinol. Outlines technical recommendations including mechanical, corrosion, and biocompatibility testing. Provides consensus standard references and terminology to aid […]

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