Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US

Set Alert for US

US FDA Transparency Win: Sponsors Know More Product-Specific Guidances Coming, Requests Fall

After creating a list of anticipated product-specific guidances to be published for generic sponsors and increasing PSG production, public requests for the agency to write a PSG declined.

Generic Drugs Guidance Documents

Cost Of Reviewing Drugs With AI Is ‘Prohibitive’ For US FDA

A public-private partnership or other solution may be needed for the FDA to handle the costs of reviewing the growing number of drug applications with AI and machine learning components, CDER Director Patrizia Cavazzoni said.

Artificial Intelligence FDA

Project 5 In 5: US FDA Oncology Office Seeks Pragmatic Trial Proposals From Clinicians, Patients

Industry has been slow to embrace the idea of pragmatic clinical trials with streamlined data collection, so the Oncology Center of Excellence now is turning to the broader cancer community for research proposals.

Clinical Trials Post Market Regulation & Studies

Global Pharma Guidance Tracker – April 2024

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.

Guidance Documents Regulation

Don’t Stop Manufacturing Because Of An Inspection, FDA’s Cavazzoni Says

The FDA drug center director is encouraging manufacturers to contact the agency’s shortage surveillance team before making rash decisions during or right after an inspection. 

Manufacturing Supply Chain

ORA Chief Says Inspections In Jeopardy Without Additional Funding

The US FDA’s Office of Regulatory Affairs is facing challenges in retaining and hiring new staff, which will impact inspections, ORA chief Michael Rogers said. 

Manufacturing Review Pathway

Drug Promotion: Sponsors Are Running Afoul Of US FDA’s CFL Guidance

Recent Office of Prescription Drug Promotion enforcement letters provide several learnings, including the need to be aware of a product’s regulatory history and competitive landscape when developing promotions that are consistent with FDA-labeling, experts said.

Ad Complaints Advertising, Marketing & Sales

The Future of ACIP: CDC Vaccine Policy Lead Looks Beyond COVID

The CDC’s Melinda Wharton discusses how the ACIP handled COVID-19 and how the pandemic will shape the committee’s work in the future. 

Advisory Committees Vaccines

Medicare Negotiation Second Cycle Draft Guidance Offers Options For ‘Effectuating’ Prices

The mechanics of implementing the new prices is the most significant update in the draft. The few revisions to key elements of the negotiation process in the guidance include alternative approaches to forums for collecting patient input on the selected drugs. 

Reimbursement Medicare

Medicare Negotiation Timeline For Prices To Be Implemented In 2027

The schedule for the second round of negotiations is different from the first cycle, in part because the Inflation Reduction Act allowed for extra time initially as the program launched. The first- and second-year timelines also overlap: The second negotiation cycle will begin before the first cycle prices are implemented. 

Medicare Pricing Debate

What’s The Key To Successful R&D With Artificial Intelligence? ‘Bilingual’ Scientists

Before J&J’s former chief data scientist Najat Khan moved to Recursion, she talked to the Pink Sheet about how AI is transforming trials and driving collaboration between industry and regulators.

Artificial Intelligence Clinical Trials

Pink Sheet Podcast: US FDA Adcomm Reform, Clinical Trial Modeling Boost, AI For Drug Review

Pink Sheet reporter and editors discuss what an upcoming listening session means for the FDA’s advisory committee reform effort, the agency’s efforts to help clinical trial modeling and simulation, and the UK’s MHRA plan to use artificial intelligence to assist in drug reviews.

Advisory Committees Clinical Trials

US FDA Inspectors, Product Centers Working Closer Together Ahead Of ORA Reorg

Compliance functions will be moved to the product centers when ORA becomes the Office of Inspections and Investigations, and centers will become responsible for making the final agency decision on inspection classifications, Associate Commissioner Michael Rogers said.

Enforcement Quality

Not-For-Profit Models Needed For Commercially Unviable Rare Disease Drugs

Developing drugs for some rare diseases is “just not commercially feasible,” meaning that alternative approaches, such as funding through venture philanthropy and not-for-profit models, need to be explored, a gene therapy professor has said.

BioPharmaceutical Rare Diseases

Wegovy's Medicare Part D Prospects: Four Million Lives And Counting?

Novo Nordisk is expecting a relatively modest uptake in Medicare Part D for the cardiovascular claim, but plans still will worry about stemming demand in obesity.

Reimbursement Medicare

ICER Debuts Clinical Trial Diversity Assessment Framework

The new tool provides a way of quantifying the degree of diversity by race/ethnicity, sex and age in clinical trials, but the results will not factor into the US health technology assessment body’s cost effectiveness determinations for new drugs.

Diversity & Inclusion Clinical Trials
See All
UsernamePublicRestriction

Register