Three circuit court decisions issued in the past two weeks have considered the CMS vaccine mandate, bringing the issue – and similar vaccine mandate lawsuits – to the Supreme Court in the final weeks of the year. The CMS...more
12/22/2021
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Employer Liability Issues ,
Employer Mandates ,
Essential Workers ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Workers ,
Motion To Enjoin ,
Popular ,
Preliminary Injunctions ,
SCOTUS ,
Stays ,
Vaccinations ,
Workplace Safety
The U.S. Food and Drug Administration (FDA) issued its third draft guidance under the Real-World Evidence (RWE) Program on November 29, 2021. In Real-World Data: Assessing Registries to Support Regulatory Decision-Making for...more
12/9/2021
/ Biologics ,
Clinical Trials ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Real World Evidence ,
Regulatory Oversight ,
Regulatory Standards
The global pandemic has accelerated the Food and Drug Administration’s (FDA) encouragement of real-world data (RWD) and real-world evidence (RWE) (the clinical evidence derived from analysis of RWD), particularly as the FDA...more
The U.S. Food and Drug Administration (FDA) issued a draft guidance titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data on October 21, 2021. The guidance provides the Agency’s thoughts...more
11/4/2021
/ Biologics ,
Clinical Trials ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Real World Evidence ,
Regulatory Oversight
The U.S. Food and Drug Administration (FDA) has issued a draft guidance for pharmaceutical companies, sponsors, and researchers sourcing Real World Data (RWD) from health records. As the FDA’s first attempt to define...more
The FDA issued a final rule (RIN 0910-A147) on August 2, 2021, to clarify its “intended use” regulations for pharmaceutical products and medical devices — 21 CFR §201.128 (drugs) and 21 CFR §801.4 (devices). The final rule...more
8/10/2021
/ Final Rules ,
Food and Drug Act ,
Food and Drug Administration (FDA) ,
Intended Use ,
Life Sciences ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Amendments ,
Regulatory Oversight ,
Regulatory Reform
On November 19, 2020, a three-judge Colorado Court of Appeals, Division I panel, unanimously affirmed a $3.6 million interest award on top of a $2.9 million verdict against Ford Motor Co. in a case involving an allegedly...more
The Northern District of California recently applied the Ninth Circuit’s ingredients list rule in a putative class action decision. The Court refused to grant Nestlé USA Inc.’s summary judgment motion based on the statute of...more