On May 11, 2017, the Senate Health, Education, Labor and Pension (HELP) Committee voted in support of the FDA Reauthorization Act of 2017, or FDARA, now formally moving through the legislative process as S. 934. The committee...more
Just as the public comment period for the bicameral, bipartisan discussion draft of the “FDA Reauthorization Act of 2017” ended on Friday, what we have been calling the User Fee Games got even more interesting and engaging....more
5/5/2017
/ Biosimilars ,
BsUFA ,
FDA Reauthorization Act ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
GDUFA ,
Medical Device User Fee Program (MDUFA IV) ,
Medical Devices ,
PDUFA ,
Prescription Drugs ,
Proposed Legislation ,
User Fees
On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting, these two...more
4/19/2017
/ Biosimilars ,
FDA Reauthorization Act ,
Federal Budget ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Legislative Agendas ,
Medical Devices ,
Prescription Drugs ,
Public Hearing ,
Reauthorization ,
User Fees
On Tuesday, President Obama signed the 21st Century Cures Act (the “Act”) into law. The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product...more
As we’ve previously reported, FDA has recently been forced to reexamine its legal position and enforcement policies related to drug and device manufacturers’ off-label communications. Although the Agency has for years...more
The summer of 2016 saw a flood of new medical device-related guidance documents coming out of FDA’s Center for Devices and Radiological Health (CDRH). Some of these draft guidance documents, such as those addressing device...more
Times, They Are A-Changin’ -
On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more
9/2/2016
/ Amarin ,
Animal Drugs ,
Biologics ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Free Speech ,
Health Care Providers ,
Medical Devices ,
Off-Label Use ,
Pharmaceutical Industry ,
Preliminary Injunctions ,
Prescription Drugs ,
Public Hearing ,
Public Safety ,
Settlement
On May 10, 2016, FDA released its first draft guidance for medical device manufacturers who are using additive manufacturing (AM), commonly referred to as 3D printing. The draft guidance, entitled “Technical Considerations...more
FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and...more
As our readers know, we write about legal developments that affect companies involved in manufacturing, importing, distributing, and/or selling “consumer products.” In many cases, these products fall squarely within the...more
7/29/2015
/ ATF ,
Consumer Product Safety Commission (CPSC) ,
Cosmetics ,
Dietary Supplements ,
Environmental Protection Agency (EPA) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Illegal Drugs ,
Jurisdiction ,
Manufacturers ,
Medical Devices ,
NHTSA ,
Over The Counter Derivatives (OTC) ,
USDA
Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international...more
In recent months, the FDA has been pushing forward in its efforts to require that more information from regulated industry be submitted electronically. The move to electronic submissions should create a more efficient and...more