Category: FDA Regulatory

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 Virtual Public Meeting on Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials

The Food and Drug Administration announceded a virtual public meeting titled “Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials.” The meeting will be convened on February 2nd and 3rd by Duke University’s Robert J. Margolis, MD, Center for Health Policy, and supported by a cooperative agreement with FDA. The meeting […]

FDA Virtual Workshop – February 16-17, 2021

FDA Virtual Workshop: Evaluating RWE from Observational Studies in Regulatory Decision-Making  The U.S. Food and Drug Administration and the Duke-Margolis Center for Health Policy will hold a two-day virtual workshop on February 16-17, 2021, focused on considerations about observational (non-interventional) study design and conduct when using evidence from observational studies to inform regulatory decisions.     FDA defines real-world evidence (RWE) as the clinical evidence regarding a medical product’s […]

The FDA issues Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan

On 01/12/2021, the U.S. Food and Drug Administration (FDA) issued the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” from the Center for Devices and Radiological Health’s Digital Health Center of Excellence. The Action Plan is a direct response to stakeholder feedback to the April 2019 discussion paper, “Proposed Regulatory Framework […]

CDER Compliance Conference

January 14, 2021 | 9:00 a.m. – 3:30 p.m. Eastern This conference is FREE and has been approved for 4.25 continuing education units for physicians, pharmacists, and nurses. See CE announcement for more details. Click here to register: https://www.fda.gov/drugs/news-events-human-drugs/cder-compliance-conference-01142021-01142021?utm_medium=email&utm_source=govdelivery In SBIA’s first conference dedicated to compliance, participants will learn from FDA subject matter experts on a range of drug compliance topics […]

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 […]

Jan-March 2021 CDER Meetings and Conferences

January Jan. 14 CDER Compliance Conference Jan. 26 Non-clinical Immunogenicity Assessment of Generic Peptide Products: Development, Validation, and Sampling Jan. 27 OTC Monograph Reform in the CARES Act: Safety Orders, Webinar Jan. 27 Public Meeting: Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act Jan. 29 Regulatory Perspectives for Development of Drugs […]

FREE Webinar: Regulatory Perspectives for Development of Drugs for Treatment of NASH

The following FDA webinar is FREE and offers SOCRA CE! Regulatory Perspectives for Development of Drugs for Treatment of NASH January 29, 2021 | 1:00 – 2:30 PM Eastern Register here: https://www.fda.gov/drugs/news-events-human-drugs/regulatory-perspectives-development-drugs-treatment-nash-01292021-01292021?utm_medium=email&utm_source=govdelivery FDA will provide a summary of FDA’s current thinking on the published draft guidance documents: Non-cirrhotic Non-alcoholic Steatohepatitis (NASH): Developing Drugs for Treatment, and Non-alcoholic Steatohepatitis […]

FDA CME/AAPA/CNE/CPE/CPT/CPH Webinar on: Biosimilar and Interchangeable Biological Products: An Updated Review of Scientific Concepts and Practical Resources

FDA Drug Topics: Biosimilar and Interchangeable Biological Products: An Updated Review of Scientific Concepts and Practical Resources January 19, 2021 Time: 1:00 pm to 2:00 pm (EDT) Register here: https://collaborationcqpub1.fda.gov/content/connect/c1/7/en/events/event/shared/94630851/event_registration.html?charset=utf-8&connect-session=breezbreeze24e7qk8muxfud8e&sco-id=221479762&utm_medium=email&utm_source=govdelivery Description: This series of educational webinars is designed to aid physicians, physician assistants, nurses, pharmacists, pharmacy technicians, certified public health professionals, other health care professionals, and […]

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 […]

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