Regulatory

The need for treatments to combat the spread of COVID-19 is promoting greater cooperation among drug regulatory authorities around the world, with FDA officials communicating more frequently with their counterparts in Europe, Canada, Japan and other nations through established programs and agreements.

Jill Wechsler details the continued rise of incorporating the “patient experience” in drug development measures.

FDA officials make efforts to better manage the increasing amount of applications for new drugs that treat disease in innovative ways and include new kinds of clinical research, starting with a plan to restructure the Office of New Drugs (OND) in the Center for Drug Evaluation and Research (CDER).

Provenance is at the heart of the discussion when it comes to the equation of privacy and provenance.

Jill Wechsler interviews FDA Commissioner Scott Gottlieb about his push for more efficient R&D to help lower drug prices.

The EU General Data Protection Regulation is the most important change in data privacy regulation in 20 years.

Meeting today’s complex regulatory demands when it comes to drug safety and pharmacovigilance can be especially challenging for small and medium-sized organizations. This report presents the benefits for these companies in outsourcing such activities to functional service providers (FSPs) during clinical trials and post-approval.

In this blog by Peter O'Donnell, the EU provides a report on the progress its made within the pediatric medicines regulation.

The rise of new drugs targeting rare disease ignites increased push for flexible R&D approaches and more collaboration on orphan drug designation and clinical trial design between global regulators.

European Parliament has voted through a resolution criticizing the performance of drug companies on pediatric medicines development. This resolution will punish drug companies who neglect to investigate possible pediatric applications of new medicines.

With a new administration in Washington, sponsors and regulators are weighing several initiatives that promise to reshape clinical research policies.

Months of rumblings across Europe that the scheme to promote orphan drugs is being abused by drug firms to maximize profit instead of innovation have been heard. Those rumblings have now turned into shouts.

While approved in 2014, Europe's new regulation governing clinical studies is set to take effect in May-leaving interested parties only six more months to prepare for its arrival.

The country’s introduction of a new legal framework has it in sync with European law on clinical research.

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Ben Rotz, Director of Medical Transparency at Eli Lilly & Company discusses TransCelerate’s Data Transparency Initiative and position paper regarding patient data de-Identification and anonymization.

The "Cures" bill and PDUFA IV are the latest measures pushing for more systematic inclusion of patient views into drug development.

With patents for many NBCDs soon to expire, the need for regulatory guidance regarding follow-on versions of these products is crucial.

Understanding the benefits of this application route in helping companies withstand the hit of patent expiries.

Organized by country and topic area, the site also allows users to compare the requirements of two countries side-by-side.

The European Medicines Agency's public consultation on yet another aspect of transparency on clinical trials data has elicited further critical comment about excessive official secrecy.

This week, I attended CBI’s Expanded Access Programs conference in Philadelphia.