The U.S. Food and Drug Administration (FDA) has just published a highly-anticipated draft guidance on the implementation of decentralized clinical trials (DCTs) for drugs, biologics, and medical devices. In the draft...more
Our Medical Device and Technology team has been at the forefront of the COVID-19 legal response since the pandemic swept across the globe. In just a few short months, our team has taken on nearly 200 matters, ranging from...more
For companies that manufacture new and novel medical devices, advisory panel meetings can be a crucial step toward receiving formal clearance or approval from the FDA. ...more
Preparing for advisory panel meetings for companies that manufacture new and novel medical devices, advisory panel meetings can be a crucial step toward receiving formal clearance or approval from the U.S. FDA. To ensure a...more
On September 1, 2017, the Food and Drug Administration (FDA or the Agency) released a final guidance document discussing the procedures for Medical Device Advisory Committee meetings (or, panel meetings). The document,...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