The Ins and Outs of Recertifications for Government Contractors
Marti Arvin and Anthony Buenger on the CMMC Framework
Nonpublication Requests For Patent Applications: Disadvantages
SBA’s New WOSB / EDWOSB Certification Requirement and 8(a) Economic Disadvantage Criteria Revisions
Compliance Perspectives: Preparing for the Certification Exams
PODCAST: Williams Mullen GovCon Perspectives - Why Was My SWaM Certification Denied, and What Can I Do?
Making Effective Use of the Claims/Disputes Process
For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE mark certifying compliance with relevant EU health and safety standards, prior to...more
In a decision characterized by the National Milk Producers Federation as a "momentous victory for American consumers, farmers and food manufacturers" and a "huge victory for worldwide producers" of gruyere cheese, the U.S....more
Over the past few weeks, landlords leasing space to the General Services Administration (GSA) have begun to receive notices of requirements that all personnel operating in GSA space certify as to whether or not they have been...more
One of the spillover effects of the COVID-19 pandemic has been the increase in opioid-related deaths. These deaths overwhelmingly affect working-class Americans with limited access and resources to lifesaving drugs such as...more
Clinical laboratories across the country have ramped up their diagnostic testing capabilities to meet the critical need for COVID-19 testing, which is essential to mitigating the spread of the virus. Many labs are responding...more
Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign Government (CFG) in order to satisfy the...more
On January 7, 2019, FDA Commissioner Scott Gottlieb announced significant updates to the FDA’s pilot Software Pre-Certification Program, sometimes referred to more broadly as a Digital Health Pre-Certification Program...more
Consumer demand for digital health care devices has soared, and it shows no signs of slowing down. But when bringing these devices to market, companies in the digital health space are confronted with numerous challenges. ...more
On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors should submit Form FDA 3674...more
On Friday, November 13, 2015, the U.S. Food and Drug Administration (FDA) released its final rule regarding Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and To Issue Certifications...more