#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 US Food and Drug Administration (FDA) recently announced its qualification of the Apple Atrial Fibrillation (AFib) History Feature through the Medical Device Development Tools (MDDT) program. The MDDT program is intended...more
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
Over the past 10 years, the Commission’s 100-day program has evolved from a pilot program launched in 2013 to codification under Rule 210.10(b)(3). Rule 210.10(b)(3) authorizes the Commission to order the Administrative Law...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” or the “Agency”) has issued a final report discussing the results of its Software Precertification Pilot Program (the “Pilot Program”). Importantly, the September 26, 2022 report...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
The Food and Drug Administration (FDA) and the National Telecommunications Information Administration (NTIA) in partnership with three domain name registries disabled nearly 30 websites illegally offering opioids for sale....more
The Food and Drug Administration (FDA) recently announced a pilot program to evaluate whether third-party food safety standards align with the food safety requirements in FDA’s Preventive Controls for Human Food (PCHF) and...more
On September 14, 2020, the U.S. Food and Drug Administration (FDA) released an update on the status of its Software Precertification (Pre-Cert) Program. It is the only public update on the program in 2020. According to the...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
In response to the rapid pace of innovation in the health and life sciences arena, the US Food and Drug Administration (FDA) is taking a proactive, risk-based approach to regulating digital health products. Software...more
In 2016, Congress passed the 21st Century Cures Act (Cures Act), which contained provisions to help accelerate medical product innovation while reducing regulatory burden, as well as to increase efforts for critical research...more
Regular readers of this blog know that we’re closely following the FDA’s proposed regulatory framework for software as a medical device (SaMD), known as precertification—Pre-Cert for short. Generally, Pre-Cert involves a...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
Please join the Hogan Lovells Communications and FDA practices on Thursday, July 25th for our webinar, Health Care and the Internet of Things: New Regulatory Developments. We will explore new policy initiatives and...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
On October 1, 2018, the Food and Drug Administration (FDA) announced a pilot expansion of the Special 510(k) Program. The Special 510(k) Program was developed to help streamline the 510(k) premarket notification process for...more
The Food and Drug Administration (FDA) recently unveiled the Quality in 510(k) (“Quik”) Review pilot program, aimed at reducing the time it takes to review moderate-risk medical devices by one-third. The pilot, dubbed as “a...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
The U.S. Food and Drug Administration (FDA) recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections for some aspects of the Preventive Controls for Human Food (PCHF) rule...more
Over the past couple of years, FDA has introduced multiple programs allowing faster review of medical devices in order to get them to market more quickly. Some of the FDA’s efforts have been highly visible, such as the...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