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
On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more
Telehealth has become an integral part of care delivery, particularly in light of the waivers instituted during COVID-19. However, these flexibilities remain in flux and at the same time, government scrutiny and enforcement...more
In one of her first official actions as Acting Chair of the Securities and Exchange Commission (SEC or Commission), Allison Herren Lee reversed a major policy implemented by recently departed SEC Chairman Jay Clayton...more
The Federal Aviation Administration (FAA) has been granting drone flight waivers for certain restricted flights to help during the COVID-19 pandemic, but the FAA says that it is unlikely the waivers will extend beyond current...more
Certain “bad actors” who settle with the SEC may be subject to automatic disqualifications or collateral consequences under federal securities laws and regulations. The Commission, however, may grant a settling party’s...more
Yesterday President Trump announced on Twitter that the U.S. was revoking California’s waiver under the Clean Air Act (CAA) which allowed it to impose stricter tailpipe emission standards than the federal ones. California’s...more
The SPC Manufacturing Waiver (the "Waiver") is now in force, effective from 1 July 2019 (Regulation 2019/933 amending the SPC Regulation 2009/469). The Waiver has been introduced with the stated aim of putting EU generic and...more
The Government Accountability Office (GAO) recently published a report on the federal government implementation of the Buy American Act. The Buy American Act of 1933 is one of several statutes implementing a preference for...more
The commercial unmanned aircraft systems (UAS or drones) market is taking off in the United States and around the world. Recent innovations have transformed what used to be considered toys into powerful tools that provide...more
Last week, on the two-year anniversary of the small unmanned aircraft systems (UAS) rule (or Part 107), a report was released by the Association of Unmanned Vehicle Systems International (AUVSI) stating that the Federal...more
Companies in a range of industries — from real estate, to agriculture, to Hollywood film production and beyond — are using unmanned aircraft systems (UAS) to improve operations or services. Most operators can accomplish their...more
In March, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its biannual report to Congress. MACPAC is an independent congressional agency that advises Congress on issues relating to Medicaid. In its...more
Generally, federal law requires practitioners to obtain a Drug Enforcement Agency (DEA) registration or a waiver from the DEA registration to use narcotics to treat opioid addiction. ...more
Last Friday, the Federal Aviation Administration (FAA) released a “refresher” on its Part 107 rule for small unmanned aircraft systems (UAS or drones) in a “Fact Sheet” available. The Fact Sheet outlines all the basics of...more
In a recent decision, the U.S. Court of Appeals for the District of Columbia Circuit determined that the U.S. Environmental Protection Agency (U.S. EPA) wrongly invoked its general waiver authority and set the volumes for...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
On Friday, President Donald J. Trump signed an executive order targeting federal regulations. This new executive action, which is designed to enact the White House’s regulatory reform agenda, requires the heads of each...more
Perspectives on Health Care and Life Sciences - Medicaid has been a vital part of the American health care safety net for more than 50 years. Today, Medicaid, along with the State Children’s Health Insurance Program...more