The product information for all pseudoephedrine-containing medicines in the EU will need to be updated, the European Medicines Agency said today.
Few plans submitted to FDA’s oncology review divisions in the wake of the April 2022 draft guidance were deemed acceptable, with enrollment goals being the most common topic of agency feedback. However, representatives from FDA and industry say the regulatory demand for such plans is pushing sponsors to build diversity into clinical trial programs from the start.
A recent externally-led PFDD meeting on kidney xenotransplantation, rather than a specific disease, allowed for more tailored patient comments on the procedure, which could impact development plans going forward.
FDA Advertising Oversight
Total ban on background music is unnecessary, agency says in denying KEI’s petition. FDA points to new ‘major statement’ rule and its previous letters objecting to a sponsor’s use of music in ads and says it will continue case by case analysis of ‘all of the elements’ in an ad.
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AstraZeneca’s Truqap and Evive’s Ryzneuta bring FDA center for drugs’ 2023 novel agent total to 51, while biologics center already sits on a record-breaking 14 novel approvals.
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.
US FDA Performance Tracker
European Performance Tracker
While a decline in complete response letters in FY 2023 is good, the continued drop in ANDA submissions could be a bad sign for the industry’s long-term health, a former FDA official worries.
In 17 suits against FDA in the last two years, firm seeks to block generics of its sleep-wake disorder drug and gain a jet lag indication. CEO Mihael Polymeropoulos tells the Pink Sheet that FDA has retaliated against Vanda for its first suit challenging a partial clinical hold on another drug.
Pink Sheet infographic breaks down the breakthrough therapy designations made by the US FDA, with statistics on what’s been approved, rescinded, and everything in between.
The vast majority of meeting requests eligible for the in-person/virtual format were not requested as such, according to Center for Drug Evaluation and Research data.
European Union reform proposals could reduce ‘clock stop’ time in drug reviews, which a new study identified as the primary driver of longer review times at the EMA compared with the US FDA.
Regulators from Canada, the UK and Australia discuss their experiences of working together under both the ACCESS Consortium, an international regulatory worksharing coalition, and Project Orbis, a parallel review process designed to speed up access to oncology medicines.
The UK joined Project Orbis in 2021 with the aim of speeding up the regulatory process for promising cancer drugs, but fewer than half of the drugs licensed under this pathway are available on the NHS in England.
The move expands access to the Pharmacopoeial Discussion Group’s quality standards to the Indian pharmaceutical industry.
Vigorous regulatory scrutiny is a given, but opinions vary about how much the companies’ respective PBM businesses present a major antitrust risk.
Pink Sheet reporter and editors discuss the FDA acknowledging reports of malignancies in patients who received CAR-T cell immunotherapies, the agency’s policy for using background music in direct-to-consumer advertising, and the FDA’s new incoming principal deputy commissioner.
A second public consultation on the review of the HTA system will be held in January to February 2024 after more than 100 stakeholder responses were received during the first consultation earlier this year.
The pharmaceutical legislation overhaul offers some solutions to the problem of immature applications.
The European Parliament has adopted changes to the proposed European Health Data Space that would protect the intellectual property of pharma companies, but trade body EFPIA says the rules should be made clearer and warned the proposed system could cause “bottlenecks”.
Japan has announced the latest evaluation results under its cost effectiveness assessment scheme. But how does it work and how much have prices been revised so far under the four-year-old program following discussions between pharma firms and authorities?
Instead of asking why confirmatory trials take so long, the FDA commissioner suggests insurance companies ask what they can do to help answer those questions.
The European pharmaceutical industry federation, EFPIA, says its member companies are not looking for shortcuts to develop and validate digital biomarkers, but want help from regulators to create the right evidence.
Low- and middle-income countries need to have the know-how, capability and capacity to produce mRNA vaccines, from concept, design and testing through to manufacturing and registration, a conference heard this week.
The number of conditional marketing authorization non-renewals could increase.
MSD and Kyowa Kirin have separately criticized England’s HTA body, NICE, for assessing their respective rare disease medicines Welireg and Crysvita using its standard appraisal pathway. Both medicines were provisionally rejected for reimbursement.
The developers of survodutide and elsunersen will be able to benefit from the early and enhanced support that the European Medicines Agency offers through its priority medicines scheme.
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