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NEWARK, Calif., JULY 30, 2018 — Regulatory Professionals, Inc., has joined Premier Research, a global provider of clinical development services, in a partnership that will offer regulatory solutions to biotechnology, pharmaceutical, and medical device companies.Read more
In October 2018, the Food and Drug Administration (FDA) issued Standard Operating Policy and Procedure (SOPP) – SOPP 8214 Version 1.0: INTERACT Meetings with Sponsors for Drugs and Biological Products. This document details recommendations forRead more
Transdermal and topical delivery systems (TDS) are important dosage forms that allow delivery of a drug to local tissue or provide systemic delivery through the skin. These drug products provide a number of advantages forRead more
As those working in the development of combination products likely know, the Food and Drug Administration (FDA) issued two new draft guidances in December 2019. The guidances – Requesting FDA Feedback on Combination Products andRead more
Earlier this week, the FDA issued a guidance on the conduct of clinical trials during the ongoing Coronavirus Disease 2019 (COVID-19) pandemic. “The FDA released this guidance to emphasize that at all times, patients’ safetyRead more
In response to the Coronavirus Disease 19 (COVID-19) pandemic, the scientific community, industry, and regulatory agencies are pulling together to facilitate the development of diagnostic tests, drugs, and vaccines to help prevent the spread ofRead more
As we continue to face health emergencies and imminent threats to our safety and well-being, the medical community is tasked with bringing solutions to the patients in an expedited and safe manner. One such opportunityRead more
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