Post Market Regulation & Studies

A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.  

Even as US FDA expressed concern about the perioperative trial design, AstraZeneca’s ability to snag NSCLC indication without demonstrating the benefits of both the neoadjuvant and adjuvant phases of therapy highlights slow pace of agency policy shifts.

HBW Insight presents a new series profiling regulatory affairs specialists working in or supporting the consumer health and cosmetics industries. In this first installment, we speak to AESGP's Christelle Anquez-Traxler and Oliver Hartmann, senior regulatory science & strategy lead, and regulatory & legal affairs director respectively. 

The first engineered cell therapy for a solid tumor could be submitted for full approval in synovial sarcoma next year.

The European Medicines Agency is seeking feedback on how to standardize the prospective planning and reporting of cardiovascular safety endpoints in oncology trials.

A Phase IV study showed that ViiV’s Dovato was non-inferior to Gilead’s Biktarvy on efficacy and produced less weight gain.

The head of CBER's Office of Therapeutic Products also touted hiring achievements and new communication plans with sponsors at an Alliance for Regenerative Medicine meeting. 

The US FDA’s new draft guidance notes its own efforts to combat misinformation and offers some creative examples to illustrate its advice, but avoids any potentially “controversial” contemporary situations.

The FDA creates a new advertising and promotion regulation safe harbor for companies who narrowly respond online to internet-based misinformation about their drugs. 

Europe’s recently launched electronic RWD catalogs as of June contained 216 registered data sources and 2,840 studies distributed across various regions of the world.

A new requirement for drug companies on how much safety stock to maintain and a mechanism for extending the expiration date of a lot or batch of a drug if there is a shortage that could cause harm are among the measures Health Canada is proposing to adopt.

The European Medicines Agency is reviewing the known risk of agranulocytosis in people taking medicines containing the painkiller metamizole, which is approved for use in most of the EU member states but banned in the US, the UK and other countries around the world.

FDA leadership weighs in on limitations of AI as part of rollout of new technology meeting program that looks to give industry and other stakeholders a chance to inform future regulation.

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits. 

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits. 

The unanimous decision that the Alliance for Hippocratic Medicine lacks standing to challenge the FDA’s relaxation of the abortion pill REMS leaves unclear whether the court would have deferred to the agency’s expertise on the merits.

Feedback is being sought on revised guidelines that tell companies how they should make post-authorization changes to their drug approvals once new rules take effect in January 2025.

Real-world data and evidence, for example generated by digital consumer health technology like apps and wearables, could provide crucial support for Rx-to-OTC switch applications, argues Sanofi Consumer Healthcare’s Penny Glover at the Association of the European Self-Care Industry's 60th Annual Meeting in Brussels, Belgium. Recent research by Sanofi indicates that regulators are actually already using RWD and RWE in many cases when assessing switch applications, even if they do not call it that. 

Ninety-two approvals, seven revocations and myriad standard-of-care treatments are all discussed in a first-of-its kind study examining the data and nuances of oncology submissions processed under Health Canada’s 26-year-old notice of compliance with conditions (NOC/c) pathway.

An internationally harmonized framework for generating adequate evidence using fit-for-purpose real-world data to address regulatory questions on the safety of medicines is out for public consultation.