A Significant Departure: Unpacking What the New Antitrust Guidelines Mean for Healthcare Providers
Medical Device Legal News with Sam Bernstein: Episode 8
Paycheck Protection Program – Common Questions and Updated Guidance
Scrutiny Increasing On Energy Private Equity Valuation
#WorkforceWednesday: Look Beyond OSHA, Accommodation Clarification, Workshare Programs - Employment Law This Week®
Employment Law Now IV-70 - Understanding the Latest EEOC Covid-19 Guidance
Episode 89 -- DOJ Issues New Guidance on Evaluation of Corporate Compliance Programs
On June 20, 2024, the FDA issued a draft guidance, “Considerations for Demonstrating Interchangeability with a Reference Product: Update” that revises the need for switching studies to demonstrate a biosimilar is...more
Intentional genomic alterations (IGAs) in animals refer to deliberate changes made to the genetic material of animals. These alterations are designed to introduce, remove or modify specific traits in animals for various...more
On April 25, 2024, the FDA published a notice of availability in the Federal Register for its revised draft guidance, entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference...more
FDA releases updated guidance regarding the Q-Submission Program; C.R. Bard faces an unusual result in its patent dispute with AngioDynamics; A nurse practitioner pleads guilty to committing health care fraud by using...more
In this segment of our series evaluating FDA’s response to the Report, we review a subset of the Report’s recommendations and responses from two CTP Task Forces—Cross Cutting and Regulation and Guidance....more
On February 9, 2023, the U.S. Department of Health and Human Services (“HHS”) announced that the Public Health Emergency (“PHE”) arising from the COVID-19 pandemic, declared under Section 319 of the Public Health Service Act,...more
Signaling a renewed focus on consumer protection in the health claims space, the Federal Trade Commission (“FTC”) has revamped its 1998 guidance titled Dietary Supplements: An Advertising Guide for Industry and extended the...more
The U.S. Food & Drug Administration (FDA) issued two new versions of guidance documents for COVID-19 tests on January 12, 2023: Policy for Coronavirus Disease-2019 Tests (the “COVID-19 Test Guidance”) and Policy for...more
The Equal Employment Opportunity Commission (EEOC) recently updated its guidelines to address employer COVID-19 testing policies. Since near the beginning of the COVID-19 pandemic, the EEOC had taken the position that...more
Given the easing of the pandemic, the US Equal Employment Opportunity Commission (EEOC) has once again updated its guidelines relating to employers’ handling of COVID-19. These adjustments reflect the evolving nature of the...more
On July 12, 2022, the Equal Employment Opportunity Commission (EEOC) updated its Technical Assistance Questions and Answers regarding “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO...more
On July 12, the Equal Employment Opportunity Commission (EEOC) updated its COVID-19 FAQs and as a result, revised certain earlier guidance regarding permissible COVID-19 testing, workplace screening, and return to work...more
After several months, the EEOC has once again updated its guidance and answers regarding the ongoing COVID-19 pandemic’s interaction with anti-discrimination laws, with a particular focus on the workplace screening, testing,...more
On July 12, 2022, the US Equal Employment Opportunity Commission (EEOC) revised its guidance on compliance with disability discrimination law during the COVID-19 pandemic. While previous guidance, initially published on...more
Now almost two and a half years into the pandemic, employers may think they have hit their stride on what to do to make sure their employees are COVID-19-free and safe. As with everything in life, you need to be up to date on...more
And, for that, we should be grateful. This week, the U.S. Equal Employment Opportunity Commission updated its guidance on COVID-19 and the laws that the agency enforces. In my opinion, it's pretty unremarkable....more
As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more
With the recent imposition of COVID-19 vaccine mandates (Mandates), some employees claim that the vaccine conflicts with their religion. So employers are being forced to ask themselves a similar question – whether their...more
On September 20, 2021, the FDA issued a revised final guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” and a third revision to its draft guidance entitled “New and Revised...more
New federal guidance on masking and testing highlighted an eventful week in the COVID-19 response, as government authorities work to respond to the rising transmission of the Delta variant. CDC Updates Masking and...more
The EEOC issued updated guidance stating that federal equal employment opportunity laws do not prevent an employer from requiring all employees physically entering the workplace to be vaccinated for COVID-19, subject to some...more
On May 28, 2021, the Equal Employment Opportunity Commission (“EEOC”) issued updated guidance regarding workplace COVID-19 vaccination policies and employee accommodations (the “Updated Guidance”). Among other issues, the...more
On May 28, the U.S. Equal Employment Opportunity Commission (EEOC) released long anticipated guidance regarding mandatory employer vaccination policies. The updated guidance confirms that, at least under federal...more
On May 19, 2021, the U.S. Food and Drug Administration (FDA) released an updated guidance in draft form on how to complete the Statement of Investigator form (Form FDA 1572). The guidance addresses frequently asked questions...more
On May 19, the U.S. Food and Drug Administration (FDA) issued final guidance for assessing the safety and compatibility of medical devices within magnetic resonance imaging facilities. The guidance applies to implanted...more