Vibha is a senior writer covering pharmaceutical and medtech regulatory developments across the globe. She plays a key role in tracking and writing about news of important regulatory issues affecting the sectors, and explaining their implications for industry. Vibha's fields of interest include the EU regulations on clinical trials, pharmacovigilance and pediatrics, on which she has written several exclusive articles from various industry conferences. She has also commissioned some pieces of expert analysis on major developments in the pharma and medtech regulatory arenas.
Latest from Vibha Sharma
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 80 documents have been posted on the tracker since its last update.
Insight obtained by the Pink Sheet relating to the European Medicines Agency’s stricter approach to requests for clock-stop extension shows that refusals have not led to any companies withdrawing their marketing applications. On the contrary, companies were able to provide responses within the agreed timeframe after all.
A new depression trial taking place across six European countries to test the safety and efficacy of multiple treatments will initially focus on repurposed drugs approved for other indications. There are plans to expand to Phase III settings and include additional treatments based on stakeholder input.
The Association of Clinical Research Organizations has awarded “seed funding” to seven US-based community clinical trial sites to demonstrate proof-of-concept projects aimed at increasing diversity in clinical trials.
The majority of clinical trials that were approved under the erstwhile Clinical Trials Directive are now governed by the Clinical Trials Regulation. The few that did not transition may be subject to corrective measures by member states.