The U.S. Supreme Court has issued its highly anticipated decision overturning the 40-year old doctrine established in Chevron v. Natural Resources Defense Council, which recognized judicial deference to administrative...more
7/15/2024
/ Administrative Procedure Act ,
Chevron Deference ,
Chevron v NRDC ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
Relentless Inc v US Department of Commerce ,
SCOTUS ,
Statutory Interpretation
While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent regulatory changes and those on the...more
Today, the U.S. Food and Drug Administration (FDA) published the draft guidance “Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products,” which provides recommendations to...more
Enacted in December 2019 as part of the Further Consolidated Appropriations Act of 2020, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (21 USC 355-2) addresses concerns that some brand...more
On Friday, the U.S. Food and Drug Administration (FDA) published the draft guidance “Psychedelic Drugs: Considerations for Clinical Investigations,” which outlines the foundational constructs for investigating the therapeutic...more
We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Boston for the first time since the pandemic. At the event, Hogan Lovells attorneys Eliza Andonova, Ina Brock, Kristin...more
The U.S. Food and Drug Administration (FDA) has several programs available that can expedite the development and regulatory review of a drug or biological product, including Accelerated Approval, which allows for approval of...more
In an official statement last week, the U.S. Food and Drug Administration (FDA) announced its conclusion that the existing regulatory framework for foods and dietary supplements is not appropriate for the regulation of...more
FDA has announced the Advancing Real-World Evidence (RWE) Program, which aims to improve the quality and acceptability of RWE-based approaches that can meet regulatory requirements in support of labeling for effectiveness...more
Last week, the U.S. Food and Drug Administration (FDA) issued the draft guidance “Considerations for Rescinding Breakthrough Therapy Designation,” which outlines how FDA will analyze whether to rescind a breakthrough therapy...more
This month, FDA released the latest in a series of agency guidance to advance the development and use of real-world data (RWD) and real-world evidence (RWE) in clinical trial designs for drug development programs. The draft...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
Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more
Last week, the U.S. Drug Enforcement Administration (DEA) released its long-awaited proposed rule on Suspicious Orders Monitoring System (SOMS) obligations under the federal Controlled Substances Act. ...more
In the prepublication version of today’s Federal Register, the U.S. Drug Enforcement Agency (DEA) issued an interim final rule (IFR) implementing conforming changes to DEA’s regulations as a result of the Agricultural...more
8/21/2020
/ Agribusiness ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Comment Period ,
DEA ,
Decriminalization of Marijuana ,
Farm Bill ,
Interim Final Rules (IFR) ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Regulatory Oversight ,
Regulatory Requirements
The U.S. Food and Drug Administration (FDA) on March 31 announced the establishment of a special emergency program to help speed actions on possible COVID-19 therapies. ...more
On March 22, the U.S. Food and Drug Administration (FDA) published the guidance “Policy for Certain REMS Requirements During the COVID-19 Public Health Emergency,” in which the agency recognizes that completion of laboratory...more
During the ongoing COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) expects that workforces will be reduced at the same time that the use of medical products will increase....more
Agency seeks input on “comparative advantage” requirement for new opioids -
Yesterday, as part of its ongoing efforts to combat the current opioid crisis, FDA published a draft guidance, “Opioid Analgesic Drugs:...more
6/21/2019
/ Applications ,
Comment Period ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Opioid ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Meetings ,
Regulatory Standards ,
Risk Assessment ,
Rulemaking Process
The U.S. Drug Enforcement Administration (DEA) announced last week that it launched a new tool for its Automated Reports and Consolidated Orders System (ARCOS) Online Reporting System that "will allow DEA-registered...more
On December 20, 2018, President Donald Trump signed the Agricultural Improvement Act of 2018 (the 2018 Farm Bill) into law.
...more
12/24/2018
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Controlled Substances Act ,
Decriminalization of Marijuana ,
Farm Bill ,
Food and Drug Administration (FDA) ,
Hemp ,
Life Sciences ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Regulatory Oversight ,
Trump Administration ,
USDA
On Thursday, August 9, 2018, Massachusetts Gov. Charlie Baker (R) signed H.4742, "An Act for prevention and access to appropriate care and treatment of addiction," which takes effect immediately.
...more
8/16/2018
/ Anti-Kickback Statute ,
Co-payments ,
Drug & Alcohol Abuse ,
Life Sciences ,
Manufacturers ,
New Legislation ,
Opioid ,
Out-of-Pocket Expenses ,
Pain Management ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
State and Local Government
On June 22 the U.S. House of Representatives passed sweeping legislation that represents "the biggest effort Congress has ever undertaken" to address the opioid epidemic, according to Rep. Greg Walden (R-OR). The House...more
Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more
4/4/2018
/ 3D Printing ,
Acquisitions ,
Artificial Intelligence ,
Biologics ,
Biosimilars ,
Biotechnology ,
Blockchain ,
Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Digital Health ,
Distributed Ledger Technology (DLT) ,
Drug Pricing ,
Emerging Markets ,
EU ,
General Data Protection Regulation (GDPR) ,
Generic Drugs ,
Innovation ,
Life Sciences ,
Medical Reimbursement ,
Mergers ,
Over The Counter Derivatives (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Private Equity ,
Regulatory Oversight ,
Supply Chain ,
Transfer Pricing ,
UK Brexit ,
Yates Memorandum
Current issues in the distribution of controlled substances
Join us for a complimentary webinar on current issues affecting the distribution of controlled substances. In an efficient hour, we will provide an overview of the...more