Michael Mezher is the Managing Editor for Regulatory Focus, a publication of the Regulatory Affairs Professionals Society (RAPS). With a focus on regulatory affairs, Michael covers news and developments in the pharmaceutical, biotechnology, and medical device industries. His articles provide insights into FDA regulations, drug approvals, clinical trials, and other regulatory issues affecting the healthcare sector.
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Michael Mezher's coverage predominantly focuses on health, pharmaceuticals, and FDA-related topics. His articles often revolve around government announcements, legal policy regulations, and press releases within the healthcare sector.
Given his focus on FDA activities and pharmaceutical developments, Michael is likely to be interested in pitches related to new drug approvals or rejections by the FDA, significant clinical trial outcomes, updates on COVID-19 vaccines or treatments, as well as regulatory changes impacting the pharmaceutical industry.
Pitches that offer insights into how specific drugs or medical devices are faring in trials or navigating regulation could resonate with Michael's coverage interests. Experts familiar with FDA processes and implications for the healthcare industry may find their perspectives valuable for engaging him effectively.
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By: Michael Mezher
Welcome to another installment of This Week at FDA, your weekly source for updates @ big and small @ on FDA, drug, and medical device regulation, and what we@re reading from around the web. This week, we learned that FDA@s final rule on laboratory developed tests (LDTs) may soon see the light of day. @
By: Michael Mezher
Welcome to another installment of This Week at FDA, your weekly source for updates @ big and small @ on FDA, drug, and medical device regulation, and what we@re reading from around the web. This week, FDA said it will seek feedback from the public on how it can optimize the use of its advisory committees, which the agency convenes to get input from external experts on some of the most difficult scientific and medical questions it faces.
By: Michael Mezher
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
By: Michael Mezher
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
By: Michael Mezher
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
By: Michael Mezher
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
By: Michael Mezher
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
By: Michael Mezher
Welcome to another installment of This Week at FDA, your weekly source for updates @ big and small @ on FDA, drug, and medical device regulation, and what we@re reading from around the web. This week, FDA announced its support for eCTDv4.0 in electronic submissions to its drug and biologics centers, the agency warned two Chinese testing firms for data integrity violations, and the National Academies has released a report calling on FDA to improve information sharing and collaboration to increase orphan drug approvals.
By: Michael Mezher
Welcome to another installment of This Week at FDA, your weekly source for updates @ big and small @ on FDA, drug, and medical device regulation, and what we@re reading from around the web. This week, FDA issued three draft guidances for its Accreditation Scheme for Conformity Assessment (ASCA) program, three clinical trial guidances, and announced the continuation of an ongoing pilot.
By: Michael Mezher
Welcome to another installment of This Week at FDA, your weekly source for updates @ big and small @ on FDA, drug, and medical device regulation, and what we@re reading from around the web. This week, FDA@issued several draft and final guidance documents, including guidance on patient-reported outcomes (PROs) in cancer clinical trials, long-term clinical neurodevelopmental safety studies for neonatal products, and requests for reconsideration at the division level for generic drug sponsors.
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