Law.com Subscribers SAVE 30%
Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.
Practice Tip: Navigating the FDA's Recent RiskMAP Guidance
As part of the Food and Drug Administration's (“FDA”) ongoing and comprehensive efforts to minimize risks while preserving the benefits of medical products, the FDA recently released three industry guidance documents on risk management strategies. These final guidance documents, applicable to various stages of drug and biological product development, will assist manufacturers in developing and improving methods to assess and monitor the risks associated with drugs and biologics. The risk minimization action plan is one of these initiatives that promises to further tip the balance of the risk-benefit profile of drugs and devices.
While FDA Guidance documents do not technically create legal obligations for manufacturers, as one writer noted, they still carry “the same weight as a 'recommendation' from the Godfather.” Barlas, S., Drug Safety Drama: FDA Opens Curtain on a New Era and New Guidance Documents, 29 Pharmacy & Therapeutics J. 752, 752 (Dec. 2004). The recently released guidance documents concern: 1) Premarketing Risk Assessment (focusing on risk assessment during the later stages of clinical development); 2) Development and Use of Risk Minimization Action Plans (focusing on specialized risk management systems); and 3) Pharmacovigilance Assessment (focusing on post-market risk assessment strategies). See Guidance for Industry: Premarketing Assessment, U.S. Dep't of Health and Human Services Food & Drug Administration (FDA), available at www.fda.gov/cder/guidance/6357fnl.htm (last modified March 24, 2005) at 1; Guidance for Industry: Development and Use of Risk Minimization Action Plans, FDA, available at www.fda.gov/cder/guidance/6358fnl.pdf (last modified March 24, 2005) at 1 [hereinafter FDA RiskMAP Guidance]; Guidance for Industry: Good Pharmacovigilance Practices and Pharma-coepidemiologic Assessment, FDA, available at www.fda.gov/cder/guidance/6359OCC.htm (last modified March 24, 2005) at 1. These guidances were produced in part to fulfill the FDA's commitment to certain risk management performance goals agreed to in relation to the Prescription Drug User Fee Act (“PDUFA”) upon its reauthorization in June 2002. Under PDUFA III, drug companies agree to pay fees that boost FDA resources, and the FDA agrees to time goals for its review of new drug applications. As the FDA works to increase its efficiency in shepherding drugs through the approval process, improvements in the way drug safety is assessed and monitored can lead to earlier identification of safety problems and enable a more proactive approach to minimizing these risks.
Role of Risk Minimization and RiskMAPs in Risk Management
This premium content is locked for Entertainment Law & Finance subscribers only
ENJOY UNLIMITED ACCESS TO THE SINGLE SOURCE OF OBJECTIVE LEGAL ANALYSIS, PRACTICAL INSIGHTS, AND NEWS IN ENTERTAINMENT LAW.
- Stay current on the latest information, rulings, regulations, and trends
- Includes practical, must-have information on copyrights, royalties, AI, and more
- Tap into expert guidance from top entertainment lawyers and experts
Already a have an account? Sign In Now Log In Now
For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473
Major Differences In UK, U.S. Copyright Laws
This article highlights how copyright law in the United Kingdom differs from U.S. copyright law, and points out differences that may be crucial to entertainment and media businesses familiar with U.S law that are interested in operating in the United Kingdom or under UK law. The article also briefly addresses contrasts in UK and U.S. trademark law.
Strategy vs. Tactics: Two Sides of a Difficult Coin
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
The Article 8 Opt In
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
Removing Restrictive Covenants In New York
In Rockwell v. Despart, the New York Supreme Court, Third Department, recently revisited a recurring question: When may a landowner seek judicial removal of a covenant restricting use of her land?
The Benefits of Blockchain for e-Discovery and Data Preservation
As businesses across various industries increasingly adopt blockchain, it will become a critical source of discoverable electronically stored information. The potential benefits of blockchain for e-discovery and data preservation are substantial, making it an area of growing interest and importance.