Regulatory

The key issues for industry and FDA as the Orphan Drug Act hits its 40th anniversary.

Reformed EMA looks to tackle challenges in drug development, pediatric medicines, and unmet medical need.

The Association of the British Pharmaceutical Industry greets the development with mix of relief and urgency.

Report by the Government Accountability Office calls for ramped-up oversight by FDA of institutional review boards.

Pandemic and supply shortage among factors in slow transition to new rules.

Probe targets agency’s role in advising on drug testing and submissions.

EMA opens public discussion on envisioned platform to encourage multi-stakeholder interactions and shared understanding.

With industry’s uneven track record in patient representation, sponsors now mandated to submit Diversity Action Plans (DAPs) to FDA for Phase III and pivotal studies.

Proposed realignment of the Office of Regulatory Affairs would impact oversight of drugs and medical devices as well.

Artem Andrianov, CEO of Cyntegrity, discusses the launch of his company's new tool; the Drug Interaction Visualizer.

Formal compliance with EU’s Clinical Trials Regulation takes effect, designed to speed up the application and approval of studies.

Face-to-face meetings will now include in-person and virtual components.

Agency panel backs the use of a common bivalent shot for all patients.

21st Century Cures Act prompts FDA to harmonize regulations.

EMA reminds the clinical trials community that the Clinical Trials Information System will be mandatory at the last day of this month.

The issues engulfing compliance with the Clinical Trials Regulation signal that even the best intentions with these types of laws may not be enough to avert unintended consequences.

Webinar Date/Time: Tue, Feb 21, 2023 11:00 AM EST

Latest recommendation places great emphasis on patients.

WHO in midst of forming group focused on developing guidance on best practices in clinical trials.

House report on Aduhelm approval calls for FDA to clarify its role in advising sponsors on drug testing and submissions.

With compliance deadline at end of month, concerns over readiness remain.

Despite agreement on recommendations between European regulators, DCT unclarity remains.

The Consolidated Appropriations Act for 2023 includes dozens of measures involving drug development and regulation.

Michelle Webb, vice president of the WCG Avoca Quality Consortium, discusses her perspectives on FDA's revised overview of inspection activities.

Insights from second annual DTRA meeting indicate DCTs are here to stay.

Automating process can reduce time and resources lost from using manual steps and allows stakeholders to maintain compliance.

A roadmap to avoiding the common pitfalls of concurrent FDA-EMA filings.

Summarizing important FDA and EMA revisions issued this year.

Navigating FDA’s draft guidance and heightened diversity recommendations.

Debates caught between focusing on existing antibiotics and developing new agents.