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
On September 26, 2017, the Food and Drug Administration (FDA) published a final guidance document providing further clarity on how FDA classifies a product as a drug, device, biological product, or a combination product,...more
On August 21, 2017, FDA solicited comments in the Federal Register on a new potential approach regarding communicating risk information in direct-to-consumer (DTC) broadcast ads for prescription drugs and biologics that...more
On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more
8/22/2017
/ Abbreviated New Drug Application (ANDA) ,
Biotechnology ,
Drug Design ,
Drug Pricing ,
FDARA ,
FDASIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Innovation ,
Medical Devices ,
New Legislation ,
Orphan Drugs ,
PDUFA ,
Pediatrics ,
Prescription Drugs ,
Product Labels ,
Regulatory Oversight ,
Trump Administration ,
User Fees
In a potential sign of renewed interest in financial ties between industry and clinical investigators, the Food and Drug Administration’s (FDA) Office of New Drugs (OND) recently issued a new Manual of Policies and Procedures...more
On June 7, 2017, FDA issued a revised guidance document, Form FDA 3674 – Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions, to clarify when sponsors should submit Form FDA 3674...more
6/14/2017
/ Abbreviated New Drug Application (ANDA) ,
Certification Requirements ,
Clinical Trials ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Guidance Update ,
Investigational New Drug Application (IND) ,
Medical Devices ,
Medical Research ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health Service Act ,
Regulatory Standards
The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat unpredictable and muddled over the last...more
Over the past few days, FDA issued three documents related to the scope of permissible communications by drug and device companies to various parties. We believe FDA aimed to accomplish two things through these documents....more
1/23/2017
/ Biologics ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
HCEI ,
Healthcare ,
Investigational New Drug Application (IND) ,
Labeling ,
Medical Devices ,
PCORI ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health