The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...more
The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows an exception from the requirement to...more
The Food and Drug Administration (FDA) recently issued a proposed rule that would extensively modify and modernize its current regulations governing the protection of human subjects and Institutional Review Boards (IRBs).1 If...more
Telehealth expanded dramatically in response to the COVID pandemic. Now that providers, patients, payers and public officials have seen the benefits, it is almost certain that telehealth will continue to play an increasingly...more
On November 15, 2018, the Food and Drug Administration (FDA) published a Proposed Rule to amend its regulations to allow waiver or alteration of informed consent requirements in certain FDA-regulated clinical investigations...more
On July 25, 2017, FDA issued a guidance document describing under what circumstances IRBs may now approve consent procedures that waive or alter some or all of the elements of informed consent as set forth in FDA’s informed...more
Joint Representation — Conflicts of Interest — Waiver - Foltz v. Columbia Casualty Company, 2016 WL 4734687 (W.D. Ok. 2016) - Risk Management Issue: Can client A's waiver, given with informed consent, permitting...more
In Sheppard, Mullin, Richter & Hampton, LLP v. J-M Manufacturing Co., Inc. (January 29, 2016 - No B256314), Division Four of the Second Appellate District rejected an advance waiver of conflicts included in a law firm’s...more
Many patients misunderstand what "informed consent" is all about. They often believe it's about signing a form ahead of surgery that acts as a waiver against any rights they may have for legal recourse if the surgery goes...more