Regulatory Affairs Professionals Society

Euro Convergence: EU pharmaceutical overhaul brings challenges, hope for better regulation

Industry representatives, patients, and regulators shared their perspectives on the reforms to the EU pharmaceutical ...
Regulatory Affairs Professionals Society

FDA finalizes guidance on designing pregnancy safety studies

The US Food and Drug Administration (FDA) has finalized guidance to assist sponsors in evaluating drug safety during ...
Regulatory Affairs Professionals Society

Asia-Pacific Roundup: Malaysia’s NPRA starts recognition procedure pilot for drugs approved by FDA and EMA

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has begun piloting a fast-track registration pathway for products ...
Regulatory Affairs Professionals Society

FDA finalizes guidance on CMC flexibilities for cell and gene therapies

The US Food and Drug Administration (FDA) has released a final guidance document with immediate effect advising sponsors on ...
Regulatory Affairs Professionals Society

FDA officials discuss new AI tool HALO, other applications of AI

Officials from the US Food and Drug Administration (FDA) discussed the launch of a new artificial intelligence (AI) system to ...
Regulatory Affairs Professionals Society

Euro Convergence: Experts discuss simplifying regulations while maintaining balance

Regulators and industry representatives highlighted the importance of simplifying regulations to promote innovation at the ...
Regulatory Affairs Professionals Society

This Week at FDA: Makary reportedly on the way out at FDA, new guidance, and more

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical ...
Regulatory Affairs Professionals Society

Pharma industry wants clarity on plausible mechanism framework

The US pharmaceutical industry expressed support for the US Food and Drug Administration’s (FDA) proposed framework for ...
Regulatory Affairs Professionals Society

European Commission publishes implementing regulation on conformity assessments by notified bodies

The European Commission on Tuesday published an implementing regulation that outlines uniform quality management and ...
RAPS

Makary announces one-day inspection pilot for low-risk facilities

DLA Piper's Vernessa Pollard (left) and FDA Marty Makary (right) spoke at the FDLI Annual Conference on Wednesday. Marty Makary, the Commissioner of the US Food and Drug Administration (FDA), ...
Regulatory Affairs Professionals Society

FDA cites firms for CGMP violations, failure to submit PMA application

The US Food and Drug Administration (FDA) has issued warning letters to several firms that have violated current good ...
RAPS

Euro Convergence: Experts weigh in on proposed MDR reforms

Left to right: Elizabeth Gfoeller, Kelly van der Geest-Aspers, Royth von Hahn, Judite Neves, Flora Giorgio, and Gert Bos. (credit: Ferdous Al-Faruque) LISBON – A panel of experts representing ...