#WorkforceWednesday®: New DOJ Whistleblower Program - What Employers Must Know - Employment Law This Week®
Berin’s Business Immigration Breakdown: A 15-Minute Look at the New Pilot Program for H-1B Visa Renewals Inside the US
DoD Cyber: A Conversation with Melissa Vice, COO for DoD’s Vulnerability Disclosure Program
[WEBINAR] Automated Vehicle Pilot Project Risks and Smart Infrastructure
Podcast - Risk Management: Revised FCPA Corporate Enforcement Policy
FCPA Pilot Program
The U.S. Food and Drug Administration recently released the guidance “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program,” laying out the process by which FDA will offer up to nine drug makers...more
Starting April 1, 2023, the U.S. Food and Drug Administration (FDA) will begin accepting requests to participate in a new Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) program to provide...more
The U.S. Food and Drug Administration (FDA) has finalized its guidance “Electronic Submission Template for Medical Device 510(k) Submissions,” which will require medical device 510(k) submissions to use FDA’s electronic...more
On June 15, 2020, the United States Patent and Trademark Office (USPTO) announced the creation of a second COVID-19 Prioritized Examination Pilot Program, this time for COVID-19 related trademark and service mark...more
In what appears to be another electronic tool in the US Food and Drug Administration’s quest to move to full digital submissions for medical devices, the eSTAR program provides 510(k) applicants with a PDF template document...more
The U.S. Food and Drug Administration (FDA) announced that it is soliciting participation in a voluntary pilot program for streamlining electronic submissions for 510(k) premarket notifications for medical devices other than...more
Where does my prescription come from? Has it been altered or diluted? Can I trust the label? With millions of prescriptions filled each year, quality control and security across the pharmaceutical supply chain seems like a...more
This morning, FDA announced it launched its new expanded access pilot called “Project Facilitate,” a concierge call center under the Oncology Center of Excellence (OCE) to facilitate the Single Patient IND (SPI) request...more
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more
Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more
In its continued effort to reduce time to market for regulated products and improve transparency, the Food and Drug Administration (FDA) published a draft guidance last Friday that, among other things, proposes to (i) expand...more
• FDA has announced new quality metrics pilot programs that seek industry stakeholder perspective and feedback. • FDA’s voluntary pilot programs target companies submitting Type C and Pre-ANDA meeting requests, as well as...more
This is the third installment of our year-in-review series covering major developments at FDA. While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more
A pilot program that could improve the efficacy of medication therapy management (MTM) services among Medicare Advantage (MA) beneficiaries would present minimal risk to federal health care programs and patients, according to...more
On December 11, 2017, the Health and Human Services Office of Inspector General (OIG) posted a favorable Advisory Opinion, permitting a proposed pilot Program involving a collaboration between a pharmaceutical manufacturer...more
Before joining Burr & Forman, I was a federal prosecutor for a little over a decade focusing on health care fraud and general white collar matters. In that role, I was a member of a prosecution team that secured guilty...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
On August 2, 2017, Attorney General Jeff Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit and a new Department of Justice (DOJ) data analytics program to combat opioid-related fraud and abuse. The...more
On July 20, 2017, FDA published two announcements in the Federal Register related to the development of an electronic, interoperable system to identify and trace certain prescription drugs distributed within the United...more
The European Medicines Agency (EMA) is planning to launch a pilot project aimed at testing the value of tailored scientific advice for the development of biosimilar medicines. Based on the analysis of analytical and...more
There is no question that the Justice Department has raised compliance program expectations in a number of areas. Whatever you may think about the efficacy or fairness of the FCPA Pilot Program, the Justice Department has...more
In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more
On June 29, 2016, the United States Patent and Trademark Office (USPTO) announced that it is implementing a pilot program to more quickly review patent applications related to treating cancer using immunotherapy. This...more