Author: komornikea

NIMHD Envisioning Health Equity Art Challenge 2020

NIMHD Envisioning Health Equity Art Challenge 2020 Art Challenge logo The National Institute on Minority Health and Health Disparities (NIMHD) is celebrating its 10-year anniversary as an Institute at the National Institutes of Health! As part of our celebration, we are hosting an art competition inviting individuals to submit images (paintings, drawings, photos, digital art, […]

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FDA will provide a summary of FDA’s current thinking on the published draft guidance documents: Non-cirrhotic Non-alcoholic Steatohepatitis (NASH): Developing Drugs for Treatment, and Non-alcoholic Steatohepatitis […]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 […]

DEBUT Challenge to award more than $100,000 in cash prizes – Submission period opens soon

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) and VentureWell are challenging undergraduate student teams to develop technology solutions to unmet needs in any area of healthcare. Three NIH partners, NIH Office of AIDS Research, the National Institute of Minority and Health Disparities, and the National Cancer Institute are providing a prize each for 1.) […]

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 […]

CDER Compliance Conference – January 14, 2021

CDER Compliance Conference January 14, 2021 | 9:00 a.m. – 3:30 p.m. Eastern This conference is FREE. Register here: https://www.fda.gov/drugs/news-events-human-drugs/cder-compliance-conference-01142021-01142021?utm_medium=email&utm_source=govdelivery TOPICS Compounding: Cleanrooms and cleanroom behaviors: why they matter Drug importation requirements Risk Evaluation and Mitigation Strategies (REMS) compliance program Drug Supply Chain Security Act implementation (DSCSA) implementation updates In SBIA’s first conference dedicated to compliance, participants […]

The Gainesville Creative Forces Virtual Arts Engagement & Telehealth Summit

The National Endowment for the Arts, Florida Division of Cultural Affairs, and The Center for Arts in Medicine is sponsoring a Creative Forces Summit Attendees will gain a better understanding of benefits, impacts, and most effective systems of delivery for the arts to support trauma-exposed rural and remote veteran populations in the community and clinical […]

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