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Michael McCaughan

Michael McCaughan has has 25 years of experience providing analysis and insight about the biopharma industry, including 10 years as Editor-In-Chief of The Pink Sheet and The Pink Sheet DAILY. He speaks frequently on regulatory and policy developments affecting the industry.

Latest From Michael McCaughan

US FDA’s ‘Platform’ Pathway Fits For LNPs And siRNA But Not Delivery Devices

The US FDA’s new guidance defining a “Platform Technology Designation” makes clear that what counts as a “platform” may not match industry’s use of the term.

Guidance Documents Review Pathway

Immuno-Oncology Add-On Trials: More May Not Be Better, US FDA Cautions

Oncology developers should ensure clinical development plans involving early-stage trials adding on to perioperative treatment regimens will show that new therapies are adding benefit in each phase, Oncology Center of Excellence Director Richard Pazdur said.

Cancer Clinical Trials

US FDA Oncology Team Says Sponsor Meetings Are Still Mostly Virtual, And That’s OK

The US FDA’s cancer drug review managers say most sponsors are happy to continue with virtual meetings, even though in-person opportunities are offered. Managers also see advantages to the virtual format for staff development.

Cancer Drug Review

US FDA Pediatric Priority Review Voucher Renewal May Come With Strings Attached

Legislation to allow the US FDA to continue awarding pediatric rare disease PRVs is moving forward, but has become the subject of partisan disagreements amid calls for new mandatory study authorities to “balance” the program.

Rare Diseases Legislation

Brand Drug Shortages Complicate US FDA Messaging To Congress

The US FDA is eager for Congress to address critical factors contributing to chronic generic drug shortages, but elected officials often are more focused on special cases like obesity drugs and ADHD treatment where the answers are very different. 

Generic Drugs Manufacturing

Patient Input In US Medicare Price Negotiation: Will CMS Close The Door?

The US Medicare agency is planning to modify its patient input process for feedback on products selected for price cuts in the program’s second year. The list of options includes holding the meetings in less public settings.

Medicare Pricing Debate
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