fda 21 cfr 177 1520
Big Data and Pharmacovigilance: Using Health Information Exchanges to Revolutionize Drug Safety
Data on individual patients collected through state and federal health information exchanges has the potential to usher in a new era of drug regulation. These exchanges, produced by recent health care reform legislation, will amass an unprecedented amount of clinical information on drug usage, demographic variables, and patient outcomes. This information could aid the Food and Drug Administration
- Part II
- Introduction to the Unified Agenda of Federal Regulatory and Deregulatory Actions-Fall 2018
Declaratory judgment actions, covenants not to sue, and bad patents: a call to allow the judiciary to weed out bad patents while adhering to the "case or controversy" requirement.
It seems incongruous that a potentially invalid patent may be allowed to remain merely because the patent owner issues a CNS. It seems equally incongruous to force a party to continue with litigation when no longer wishes enforce its patent against a...
Seeking common ground in the abortion regulation debate.
INTRODUCTION Texas State Senator Wendy Davis drew national attention in June 2013 when she staged one of the longer filibusters in United States history--nearly eleven hours--in an effort to prevent a vote on pending legislation that would "ban a...
- 872 F.3d 1290 (Fed. Cir. 2017), 2015-1177, Aqua Products, Inc. v. Matal
Adversarial science—sometimes referred to as "litigation science" or "junk science"—has a bad name. It is often associated with the tobacco industry's relentless use of science to manufacture uncertainty and avoid liability. This Article challenges the traditional conception that adversarial science should be castigated simply because it was developed for litigation. Rather,...
Internal administrative law.
ABSTRACT For years, administrative law has been identified as the external review of agency action, primarily by courts. Following in the footsteps of pioneering administrative law scholars, a growing body of recent scholarship has begun to attend ...
- Semiannual Regulatory Agenda
The continuum of excludability and the limits of patents.
III. EXPLANATORY AND POLICY SIGNIFICANCE What implications can we draw for innovation theory and policy from the continuum of excludability and from the existence of highly nonexcludable information goods of the sort just canvassed? Perhaps the mos...
- 552 U.S. 214 (2008), 06-9130, Ali v. Federal Bureau of Prisons
- 854 F.3d 1207 (10th Cir. 2017), 14-2219, State v. Department of Interior
- 809 F.3d 610 (Fed. Cir. 2015), 2014-1274, Momenta Pharms., Inc. v. Teva Pharms. USA Inc.
- Introduction to Regulatory Plan and Unified Agenda of Regulatory and Deregulatory Actions
- Part IV
- Biological products: Human cellular and tissue-based products manufacturers; current good tissue practice; inspection and enforcement,
The Vioxx litigation: disincentivizing patient safety through misdirected tort rules.
THOUGH MANY believe that the tort system provides the best incentive for manufacturers to promote and manufacture their products safely, (2) the Vioxx litigation proves that the tort system can act as a disincentive against manufacturer transparency,...
- 38 F.3d 43 (1st Cir. 1994), 94-1074, Adams v. United States E.P.A.
- Regulatory Implementation of the Centers of Excellence and Expertise
Patent cases and public controversies.
INTRODUCTION A patent could be described as a private solution to a public problem--the government grants to an inventor a private exclusive right to his invention for a limited time in order to encourage the promotion of progress to benefit the pu...
- 530 F.2d 515 (3rd Cir. 1976), 75--1282, A. O. Smith Corp. v. F. T. C.
- 825 F.3d 674 (D.C. Cir. 2016), 15-1063, United States Telecom Association v. Federal Communications Commission And United States of America
- Regulatory Agenda:
Leave time for trouble: the limitations periods under the securities laws.
I. INTRODUCTION II. THE LIMITATIONS PERIODS UNDER THE SECURITIES LAWS A. The Purposes of the Securities Laws ' Limitations Periods 1. Allowing Sufficient Time to Investigate and File a Securities-Fraud Case 2. The "Stale Evidence" Rationale 3. The "L...
- Consolidated Omnibus Budget Reconciliation Act: Semi-annual agenda