FDA Boot Camp

Rapid shifts since March 2025 have touched expedited programs, diagnostics oversight, AI and ML change control, OTC transitions under ACNU, and promotional enforcement in short-form media. At the same time, the FDA has unveiled the new Commissioner’s National Priority Voucher (CNPV) Pilot and has been releasing Complete Response Letters with heightened transparency, both of which are reshaping regulatory priorities. This year in review separates binding requirements from guidance and proposals to set clear priorities for the conference.

Topics of discussion include:

• FDA leadership transitions and exodus and the potential effects on industry
• Monitoring regulatory priority shifts under Trump 2.0, including those arising via the MAHA commission/RFK Jr.
• Analyzing their healthcare agenda and the downstream effects on FDA regulatory matters
• Distilling what is binding versus what is guidance or proposal
• Assessing the impact of the CPNV Pilot on product development incentives and FDA’s enforcement bandwidth
• Reviewing how FDA’s “radical transparency” efforts and evolving approach to Complete Response Letters is changing sponsor strategies and transparency expectations
• Adjusting to FDA’s swing in regulatory enforcement on Direct-to-Consumer advertising

Late pivots on confirmatory evidence, real-world evidence, or cross-center coordination can add months when least expected. This session turns approval fundamentals into a forward plan that designs pivotal evidence with confirmatory needs in mind and choreographs device or diagnostic touchpoints to protect speed and quality.

Topics of discussion include:

• Designing pivotal programs while anticipating confirmatory study expectations
• Integrating external controls and real-world evidence without triggering avoidable pushback
• Coordinating drug, device, and diagnostic interfaces and sequencing key FDA meetings

Companies can use FDA’s expedited review programs to enhance their regulatory strategies and reduce the time-to-market for their new products. This session covers the expedited review programs for drugs, including the latest developments with the Commissioner’s National Priority Voucher (CNPV) program.

Topics of discussion include:

• Criteria for the CNPV, Priority Review, Breakthrough Therapy, Accelerated Approval, and Fast Track programs
• Recent developments with the CNPV Program
• Key considerations for companies before seeking expedited review

Moving a prescription product to nonprescription status broadens reach only if conditions-of-use and self-selection evidence answer real-world risks. This session contrasts ACNU with the Monograph route and outlines a data and labeling path that travels from submission to shelf without surprises.

Topics of discussion include:

• Choosing ACNU versus Monograph strategically and scoping fit-for-purpose datasets
• Demonstrating comprehension and self-selection and planning label-comprehension studies
• Monitoring post-market performance and updating labeling responsibly

Enrollment stalls, diversity misalignment, and decentralized-trial hiccups can derail timelines even when the science is sound. This session turns statutory diversity and DCT realities into documentable plans that reviewers trust and sites can deliver.

Topics of discussion include:

• Drafting diversity action plans and requesting waivers with defensible rationales
• Selecting sites and networks to achieve representation benchmarks
• Maintaining data integrity and monitoring decentralized and hybrid execution

Portfolio gaps, mis-listings, or mistimed exclusivities undercut hard-won approvals. This block frames patent scaffolding, Orange Book positioning, and naming choices so legal and regulatory tracks reinforce each other from IND through launch.

Topics of discussion include:

• Summarizing core patent tools for drugs and biologics and structuring durable portfolios
• Listing and delisting Orange Book patents and crafting carve-outs and skinny labels
• Coordinating exclusivities (NCE, orphan, pediatrics, reference product, interchangeability) and timing lifecycle moves to protect entry windows

Getting a follow-on product to market means balancing speed, cost, and the risk of litigation. This session walks through the core requirements for small-molecule and biologic entry, showing how sameness, bioequivalence, biosimilarity, and interchangeability standards drive strategy. It also explains how timing notices, stays, and the “patent dance” can protect a launch window or undermine it.

Topics of discussion include:

• Comparing NDA, 505(b)(2), and ANDA routes and evaluating Paragraph IV strategies
• Demonstrating sameness and bioequivalence and addressing complex-generic edge cases
• Defining biosimilarity and interchangeability and anticipating payer and formulary effects
• Timing notices and stays and deciding how to engage in the patent dance

The label is where approval ends and liability begins. Unclear claims or thin risk language echo through promotion, REMS, pharmacovigilance, and litigation. This session shows how to anchor evidence in the PI, anticipate post-market evolution, and use change control to avoid costly relabeling.

Topics of discussion include:

• Surveying labeling requirements and exploring the end-to-end review pathway
• Incorporating clinical data accurately and appreciating downstream post-market effects
• Amending labels after launch and leveraging label strategy in product-liability defense
• Pursuing carve-outs and navigating skinny and narrow labeling where appropriate