The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time FDA employees is raising...more
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community.
The value of merger and...more
2/21/2025
/ Acquisitions ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Investors ,
Life Sciences ,
Mergers ,
OIG ,
Pharmaceutical Industry ,
Private Equity ,
Regulatory Requirements ,
Risk Management
The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, has prompted many in the life sciences industry to question how this political shift...more
On May 21, 2024, The Drug Enforcement Administration (DEA) issued a notice of proposed rulemaking in the Federal Register (FR) to reschedule marijuana from Schedule I to Schedule III of the Controlled Substances Act (CSA)....more
The Centers for Medicaid and Medicare Services (CMS) announced a model on February 14, 2023 that would allow CMS to pay less for drugs approved via FDA’s accelerated approval pathway before a clinical benefit has been...more
In a May 27 Federal Register notice, the US Department of Health and Human Services (HHS) announced the reinstatement of the Unapproved Drugs Initiative, the FDA’s compliance policy governing marketed unapproved drugs. The...more
Companies marketing products or services for coronavirus (COVID-19) should be aware of key areas of healthcare law and regulation, including Food and Drug Administration regulation, clinical laboratory testing oversight,...more
7/9/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Clinical Laboratory Testing ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Immunity ,
Product Defects ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Risk Mitigation ,
Suppliers ,
Supply Chain ,
Telehealth
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
3/6/2020
/ Biologics ,
Biotechnology ,
Clinical Laboratories ,
Clinical Trials ,
Data Collection ,
Data Management ,
Department of Health and Human Services (HHS) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Generic Drugs ,
Informational Studies ,
Life Sciences ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
Research and Development