The Presumption of Innocence Podcast: Episode 48 - Digital Boundaries: Fourth Amendment Protections in a Connected World
eDiscovery Needs Digital Forensics for a Mobile World
A Sneak Peek into Data Mapping: What Implementation Really Looks Like
It's Time to Think About Data Mapping Differently
EEO-1 Filing After June 4: What to Do Now, and How to Prepare for Next Year - Employment Law This Week®
Navigating State Privacy Laws
[Webinar] You Are Here: First Steps in Data Mapping
An Ounce of Prevention: Keys to Understanding and Preventing AI and Cybersecurity Risks
Calculating eDiscovery Costs: Tips from Brett Burney
State AG Pulse | Content moderation vs. free expression
Work This Way: A Labor & Employment Law Podcast | Episode 14: How Employers Can Navigate Cybersecurity Issues with Brandon Robinson, Maynard Nexsen Attorney
Navigating the Digital Frontier: Employee Privacy Rights and Legal Obligations in the Modern Workplace
DE Under 3: OMB Announced Finalized Overhaul to Federal Race & Ethnicity Data Collection Standards
Embracing Data Privacy to Drive Business Growth: On Record PR
Work This Way: A Labor & Employment Law Podcast - Episode 6: Digital Forensics & Protecting Trade Secrets with Clark Walton
PODCAST: Williams Mullen's Trending Now: An IP Podcast - U.S. State Data Privacy Update
Managing Large Scale Review Efficiency: Tips From a GC
AD Nauseam – Children, They are Indeed Our Future – COPPA Developments
1071 Rule Status — The Consumer Finance Podcast
Data Dividend: What is Personal Data Worth?
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
The Food and Drug Administration (FDA) has issued new draft guidance, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (the Draft Postmarketing...more
In a move akin to last-minute gift-giving, the Departments of Labor, Health and Human Services, and the Treasury (the “Departments”) released FAQ 56 on December 23, 2022, which provides relief regarding the Prescription Drug...more
In December 2016, fifteen Food and Drug Administration (FDA) officials, including then-Commissioner Robert Califf and current Acting Commissioner Janet Woodcock, published an article in the New England Journal of Medicine...more
The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a drug’s benefits, risks, and...more
Pharmaceutical advertising is big business. In 2020, pharmaceutical companies spent more than $6.5 billion on advertising. The Food and Drug Administration (FDA) regulates advertisements of prescription drugs, but it...more
On July 9, 2021, President Joe Biden announced a broad executive order (the “Order”) intended to boost what it characterizes as stagnant competition across the U.S. economy. The Order, among other things, encourages the...more
The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more
Information Collection Request. On November 27, 2019, 340B Health, a nonprofit membership organization comprised of hospitals and health systems that participate in the federal 340B drug pricing program (“340B Program”),...more
On September 30, 2019, the Centers for Medicare and Medicaid Services (CMS) published a notice to inform hospitals that it will be surveying hospitals to collect information regarding hospitals’ acquisition costs for...more
Welcome back to the Class Action & MDL Roundup! This year has begun with cases all over the map, from California to Florida to Massachusetts. The West Coast features overbearing manufacturers, allegedly underpaid lenders,...more
On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are...more
As previously discussed in our post from September 2017, the push for a response to the opioid crisis is gaining momentum. Enter the “Opioid Crisis Response Act of 2018.” On May 7, 2018, the Opioid Crisis Response Act of...more
This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more
On September 8, 2015, the House of Representatives passed a bill intended to combat prescription drug abuse through the reauthorization of a program that provides federal grants to states for prescription drug monitoring...more