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French Regulator At Odds With EMA Over Safety Restrictions For Pseudoephedrine
The product information for all pseudoephedrine-containing medicines in the EU will need to be updated, the European Medicines Agency said today.

Clinical Trial Diversity Plans: Early Oncology Experience Shows More Work Needed, US FDA Says
Few plans submitted to FDA’s oncology review divisions in the wake of the April 2022 draft guidance were deemed acceptable, with enrollment goals being the most common topic of agency feedback.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.

US FDA’s Patient-Focused Drug Development Program Meetings Evolve With Technology Focus
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
Background Music During Risk Segment Of Rx Drug Ads: FDA Explains Its Policy
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.
US FDA’s ‘Incremental Step’ On Rx Ads: A Long Time Coming
Rx Drug TV Ads Must Present ‘Major Statement’ Simultaneously In Audio & Visual Segments
Accelerated Approval Drug Promotions Run Risk Of Overstating Efficacy, Understating Safety
If The ‘SIUU’ Fits: The New Vocabulary Of US FDA ‘Off-Label’ Policy
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Pink Sheet Podcast
Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.
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Keeping Track: US FDA Drugs Center Passes 50 Novel Agent Approvals In 2023
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.

Global Pharma Guidance Tracker – October 2023
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
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Generics Review Data From US FDA Reveals Positives, Negatives For Industry
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.

Vanda Launches Barrage Of Suits Against FDA Seeking To Retain Hetlioz Market
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.

Data on Designations: What’s Happened To BTDs Over The Years
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.

Sponsors Still Not Racing To Schedule In-Person Meetings With US FDA
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.
Regional Comparisons

Watching The Clock Stop: US/EU Regulatory Review Time Parity In Sight, Study Suggests
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.

International Regulators Say Collaboration Is Key To Tackling Pharma Globalization Challenges
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.

Project Orbis: More Cancer Drugs Available In Scotland Than England
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.

EU-US-Japanese Pharmacopeia Group Accepts India As First New Member in Decades
The move expands access to the Pharmacopoeial Discussion Group’s quality standards to the Indian pharmaceutical industry.
Recent Stories
The Next Big PBM Deal? Rumored Cigna-Humana Talks Raise Overlap Question
Vigorous regulatory scrutiny is a given, but opinions vary about how much the companies’ respective PBM businesses present a major antitrust risk.
Pink Sheet Podcast: CAR-T Malignancy Reports, Background Music In DTC Ads, New No. 2 At US FDA
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.
‘Vast Amount Of Valuable Input’ Leads Australia To Extend HTA Review
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.
Premature Filings Add To EU Regulatory Resource Challenge
The pharmaceutical legislation overhaul offers some solutions to the problem of immature applications.
EU Parliament Says Pharma IP & Trade Secrets Must Be Protected Under Health Data Space
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’s CEA Scheme: How It Works And Impact So Far
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?
US FDA’s Califf: Payers Should Ask How They Can Help Answer Clinical Research Questions
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.
EU Pharma Wants Regulators’ Help To Simplify Digital Endpoints Landscape
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.
Partnerships Are Key To Sustainable mRNA Vaccine Production In LMICs
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.
Early Advice Could Help Companies Maintain EU Conditional Marketing Authorizations
The number of conditional marketing authorization non-renewals could increase.
MSD & Kyowa Question NICE’s Processes After English Funding Rejected For Rare Disease Drugs
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.
Drug Candidates For NASH & Epilepsy Disorder Secure EMA PRIME Designations
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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