There are pending requests to add 13 candidates to the tropical diseases that qualify for a priority review voucher, according to a Pink Sheet analysis, as FDA Commissioner Robert Califf faces congressional pressure on the years since the list's last update.

A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.

FDA officials have said hiring could be slowed if an inflationary pay increase is not included in the agency budget, but CDER and CBER continue to add staff at a steady pace.

BIMO inspections and investigators have declined since 2017, and investigators express frustration to the Government Accountability Office that their inspection classification recommendations are downgraded by the Center for Drug Evaluation and Research.

EMA charges participants to receive scientific advice through the fledgling program, unlike the US FDA, which may not fit the budgets of some complex generic sponsors. At the same time, sponsors also may simply not be aware the program exists yet.

Acknowledging that it may be a barrier to some extent, EMA’s senior scientific specialist of clinical pharmacology Kevin Blake notes that EU reference medicinal products are a legal requirement for bioequivalence studies and cannot be circumvented.

While EU preparations are underway to introduce strict legal requirements for all AI systems, the UK has doubled down on its flexible, non-regulatory framework. In this second of a two-part article, a lawyer explains the pros and cons of each for pharma and medtech firms.

Flexible thinking and rigorous standards will both be needed to develop psychedelics as drug therapies in order to surmount the many complicating factors, from unique ‘set and setting’ aspects to functional unblinding, speakers at Reagan-Udall Foundation meeting agree.

There are pending requests to add 13 candidates to the tropical diseases that qualify for a priority review voucher, according to a Pink Sheet analysis, as FDA Commissioner Robert Califf faces congressional pressure on the years since the list's last update.

Pink Sheet reporter and editors discuss the impact of FDA biosimilar promotion guidance on the future of the interchangeability designation, upcoming guidance on accelerated approval for gene therapies, and partisan attacks on the agency from Capitol Hill.

The European Medicines Agency believes Idorsia’s Jeraygo should be approved for use in the EU at two different doses rather than just the one approved by the US Food and Drug Administration last month.

The European Commission’s landmark AI Act will introduce strict new rules for AI systems, with the exception of products used solely for scientific research, something that could be good news for pharma, according to industry body EFPIA.

The European Health Data Space is expected to give researchers, industry and public bodies access to large amounts of high-quality health data for the development of new treatments and vaccines. The European Parliament has also approved new rules on Substances of Human Origin.

About 10% of marketed medicines chosen at random in Denmark had “non-functioning” anti-tamper devices, leaving them open to possible interference.

Real-world evidence and patient involvement can help developers shore up evidence from single arm trials for EU-wide joint clinical assessments.

Experts discussed regulatory science issues at a recent forum in South Korea, including the responsibilities of sponsors and regulators as well as the need to strengthen collaborations and accelerate the development of innovative drugs and converged medical products.

Seeking to clear up a ‘misconception,’ Oncology Center of Excellence officials say earlier endpoints, such as progression-free survival and overall response, continue to be useful in getting therapies to market quicker, but sponsors still should plan to systematically collect OS data to ensure there is no detriment to survival.

The statement, which is part of a final rule on the 340B administrative dispute resolution process, could facilitate manufacturer efforts to seek repayments from hospitals in such cases.

US FDA Commissioner Robert Califf tells Congress that regulators don’t have to know how artificial intelligence works in medicine, but must make very sure it actually does work.

Clarke helped launch GDUFA I and negotiate GDUFA II, chaired the CDER Executive Committee and oversaw many other programs in the US FDA’s drugs center.