DESCRIPTION
The approval process…pre-approval concerns…product labeling… clinical trials…adverse events reports…patent concerns…exclusivity… All are critical aspects in the commercialization process for drugs, biologics, and devices that are governed by FDA law and regulation. Plus, the FDA Amendments Act of 2007 (FDAAA) is one of the most comprehensive revisions of FDA law in decades. And recent court cases and high-profile trials concerning FDA-regulated products have made it clear that it is essential for attorneys who do not have regulatory practices — but who do deal with FDA-regulated products — to have a familiarity with these concepts. The same can be said of securities experts and business executives in the life sciences arena.
Products liability and patent litigation concerning these products often hinges on what happened during the pre-approval, approval, or post-approval periods.
However, many products liability lawyers, patent counsel, and business and investment experts — despite their tenure in working with FDA-regulated products — are not well-versed in the essentials of the approval process and the regulatory hurdles of the post-approval period.
ACI’s FDA Boot Camp has been designed to give products and patent litigators, as well as patent prosecutors and life sciences investment and securities experts, a strong working knowledge of core FDA competencies, including the nuances of FDAAA.
A distinguished faculty of top FDA regulatory experts — a “Who’s Who of the FDA Bar” — will share their knowledge and give you critical insights on:
- The organization, jurisdiction, functions, and operations of the FDA
- The essentials of the approval process for drugs, biologics, and devices, including:
- NDAs
- OTC Approval
- INDs
- 510(k) submissions
- BLAs
- PMA process
Foley Hoag Partner, Paul Kim, is the Co-chair of the event and speaking on From Theory to Practice: FDAAA, Future FDA and Legislative Priorities, Other Enforcement Initiatives, and Beyond
- FDAAA – how companies must now adapt
- implementation considerations
- avoiding civil penalties and fines for noncompliance
- Overriding philosophy, goals, and priorities of the FDA at this juncture and what to expect to be high on the agency’s agenda
- What now sparks an FDA investigation?
- Steps to take after receiving warning letters
- Consent decrees: what you now must know
- Other significant recently enacted and proposed legislation and their food and drug implications
- Sunshine Acts and other bills requiring additional disclosures and greater transparency
- proposed amendments to the Federal False Claims Act
- analysis of increased legislative activity at the state level
- developing methods for tracking and complying with diverse requirements
Partner Jayne Bultena is speaking on The Basics: Understanding and Working with the FDA — Jurisdiction, Functions, Organization, and Operations.
- FDA Overview
- How the FDA is organized
- Department of Health and Human Services and the Commissioner
- The 5 FDA Centers and the Office of Regulatory Affairs and their functions
- The 3 major centers and their roles
- CDER (Drug)
- CBER (Biologic)
- CDRH (Device)
- Understanding how CDER and CBER intersect
- Defining the scope of the FDA’s jurisdiction
- Examining how the FDA exercises its jurisdiction:
- rule making
- product decisions
- enforcement
- informal mechanisms
- Reviewing the laws that the FDA enforces
- Food Drug & Cosmetic Act
- Prescription Drug Marketing Act
- Public Health Services Act
- Hatch-Waxman Act
- other applicable laws
- Defining drugs, biologics, and medical devices
- Labeling: when is a drug a drug and not a medical device or cosmetic, and the consequences
- Defining combination products
- Working with the FDA
- Administrative Procedures Act
- formal and informal dispute resolution mechanisms
- FDA’s policies and procedures
- When will DOJ prosecute?
- Understanding government enforcement tools and procedures
- Current enforcement priorities as evidenced by recent investigations
- Identifying conduct that can trigger government scrutiny
- How recent large settlements should be reflected in risk mitigation strategies
- Clinical trials for drugs and biologics and the clearance process for devices
- The classification of devices and the concept of “risk-based” classification
- The role of the Hatch-Waxman Act in the patenting of drugs and biologics
- Labeling in the drug and biologics approval process
- cGMPs and other manufacturing concerns relative to products liability
- Proactive adverse events monitoring and signal detection
- Requirements for post-approval advertising and promotion
- Recalls, product withdrawals, and FDA oversight authority
- Current government enforcement priorities and key legislative initiatives