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US Supreme Court’s EPA Ruling Expected To Have Limited Impact On FDA Regulations
Court restricts EPA’s ability to regulate greenhouse gas emissions saying agency must have “clear congressional authorization” to address “major questions.” Decision is not likely to pose a problem for the FDA unless it were to regulate something new, attorneys say.

UK Must Act Now To Reverse Decline In Life Sciences Sector
A new industry report has painted a sobering picture of the UK life sciences sector, which is facing challenges on a number of fronts including clinical research, market access and manufacturing. On the bright side, the report says that implementing the measures in the government’s Life Sciences Vision could make the UK a “world-leading” hub for drug discovery and development.

US FDA Appears To Quickly Renege On Next-Gen COVID Vaccine Guidance With Updated Booster Announcement
After issuing guidance and making public statements saying the first updated COVID-19 vaccines would require clinical trial data, agency picks new vaccine composition that will make obtaining such data highly unlikely before a planned fall booster campaign.
Aduhelm: One Year On
The Story of Aduhelm, From Early Studies To Commercial Demise
Our graphical timeline walks you through the most significant events in the history of the Alzheimer’s drug, including the tumultuous last year.
Aduhelm, One Year Later: US FDA’s Credibility, Accelerated Approval Pathway Feel The Bite From Alzheimer’s Drug Approval
Medicare Coverage Restrictions For Expensive Drugs: Did Aduhelm Let The Genie Out Of The Bottle?
How Biogen’s Aduhelm Bet Became A Commercial Bust
Aduhelm Label Update Includes Seizure Risk And Recommends More MRIs
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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: Tumor-Agnostic Approval For Novartis; Submissions From Krystal, Menarini, And Astellas
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
US FDA Performance Tracker

Global Pharma Guidance Tracker – May 2022
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.
European Performance Tracker
Policy & Regulation Explore this Topic
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Latest From Regulation
EU CHMP Opinions and MAA Updates
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
Is It Time To Think Beyond mRNA For COVID Vaccines? FDA Advisors Intrigued by Novavax As Booster
Many VRBPAC committee members said they were impressed with Novavax’s booster data, including with its prototype vaccine, raising questions about whether non-mRNA vaccine platforms may be preferable to address COVID long-term.
Operation Warp Speed For Rare Diseases? US FDA Is Considering Pilot Programs
CBER director Peter Marks says the FDA may evaluate giving gene therapy products the ‘degree of responsiveness’ that COVID-19 vaccines received. In a discussion of the pandemic's effects on staff retention, CDER director Patrizia Cavazzoni says attrition rates are back to historical levels.
After 10 Years, US FDA ‘Additional Conditions’ Proposed Rule Offers ‘Novel Switch’ Pathway
Publication of "ACNU" proposed rule wasn’t reached in a straight line and featured coining another term with a more of a regulatory sound, “NSURE.” The proposed rule also detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.
Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval Process
The “Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFL isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.
EU Targets Generics, Inspection Shortfalls & Environmental Assessments
As the European Commission prepares to publish its proposals for overhauling the EU pharmaceutical legislation at the end of the year, member states have been discussing a range of technical and legal issues such as the scope of the centralized approval procedure, the use of electronic product information and the shortage of inspection capacities.
Latest From Policy
Patient-Focused Drug Development Guidance: Determining When A Clinical Outcome Assessment Is Appropriate
A US FDA draft guidance on selecting and developing fit-for-purpose clinical outcome assessments specifies the evidence that can be provided to support using a COA in a particular context.
Medicare Part D Coverage For Obesity Drugs Urged By House Appropriations Panel
In the report accompanying FY 2023 HHS appropriations legislation, the House committee also addresses biosimilar uptake in Part D, Medicare dispensing fees for oral COVID-19 drugs and NIH grants for expanded access to investigational ALS drugs.
England: HTA Body NICE Makes Big RWE Push
England’s health technology appraisal institute, NICE, has published its real-world evidence framework.
Clinical / R&D Explore this Topic
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Latest From Research & Development
US FDA’s Science Strategies Program Aims To Proactively Tackle Drug Development Hurdles
The goal of the Office of New Drugs’ initiative is to develop and execute, in a cross-disciplinary manner, strategic plans to address substantive development hurdles in specific therapeutic areas. This approach already has been used for non-healing, chronic wounds and is being expanded to neurodegenerative and rare diseases, OND’s Peter Stein tells the Pink Sheet.
RSV Vaccine May Be On Market In 2023, CDC’s ACIP Anticipates
Panel expects to review five respiratory syncytial virus vaccines and vote on one or two of them in June 2023 and others four months later. Sanofi presents results of three clinical trials of its monoclonal antibody nirsevimab, which is on track to be the second RSV prophylaxis for infants.
Califf: More Expedited Approvals Mean US Clearance Only The Beginning Of Learning About Medical Products
The US FDA commissioner said increased use of expedited approval pathways will help spur clinical research system reform.
Commercial Explore this Topic
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Latest From Commercial
Citeline And Norstella Merge To Provide End-To-End Solutions For Pharma
Publisher’s Spotlight: Citeline, the publisher of Pink Sheet, is to merge with fellow pharmaceutical solutions provider Norstella.
After 10 Years, US FDA ‘Additional Conditions’ Proposed Rule Offers ‘Novel Switch’ Pathway
Publication of "ACNU" proposed rule wasn’t reached in a straight line and featured coining another term with a more of a regulatory sound, “NSURE.” The proposed rule also detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.
BIO 2022 Notebook: Future Directions For R&D
News and views from day four of the BIO annual meeting include a fireside chat with FDA commissioner Robert Califf, gene therapy insights, and pharma efforts to provide cancer medicines in lower income countries.
Manufacturing Explore this Topic
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Latest From Manufacturing
HHS OIG: US FDA Inspection Manual Revision Could Reduce Unannounced Inspections Abroad
Poor inspection history was dropped as a criteria for unannounced inspections, OIG says in an audit report, even as support grows for surprise inspections of poor quality sites. An exhaustive review of foreign for-cause inspections shows the FDA reorganization has sped up a process that must go faster still. Meanwhile, whatever happened to experienced investigators’ training records?
US FDA Advisors' Push For BA.4/BA.5 COVID-19 Boosters Sets Up Regulatory, Manufacturing Crunch
If FDA wants to follow its external experts' advice on new booster composition, it would likely have to authorize BA.4/BA.5-targeting boosters on preclinical and manufacturing data only, and companies would have to quickly pivot manufacturing.
ICMRA’s Pilot On Hybrid Inspections And CMC Changes Seeks Participants
Driven by COVID-19 pandemic challenges, regulatory authorities from multiple regions want to work with sponsors on new joint approaches for expediting manufacturing changes globally and streamlining preapproval and pre-licensing inspections.
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