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Recall: prevent, manage, mitigate, and survive
- Hodgson Russ LLP
- -
- USA
- -
- February 28 2011
Surviving a medical device recall is no easy feat
FDA's final rule for combination products
- Hodgson Russ LLP
- -
- USA
- -
- January 29 2013
On January 22, 2013, the Food and Drug Administration (FDA) issued a final rule on current good manufacturing practice (CGMP) requirements applicable
FDA and CMS announce intention to collaborate in two major areas
- Hodgson Russ LLP
- -
- USA
- -
- October 6 2010
All companies within the health care industry should be aware of two recent developments in the area of medical device approval and federal health care program reimbursement
How to avoid import detention by the FDA
- Hodgson Russ LLP
- -
- USA
- -
- August 3 2011
An import detention notice from the FDA is received by many importers of foreign goods with mixed feelings of surprise, confusion, and anxiety
FDA and European Medicines Agency to do parallel evaluation of new drug marketing applications
- Hodgson Russ LLP
- -
- European Union, USA
- -
- April 4 2011
FDA is always criticized and questioned about taking longer to approve regulated products than its counterpart agency in Europe, European Medicines Agency (EMA
FDA releases CDRH action plan for 510(k) and science initiatives
- Hodgson Russ LLP
- -
- USA
- -
- January 24 2011
On January 19, 2011, the US Food and Drug Administration (FDA) released a plan for 2011 involving 25 action steps to improve the most common regulatory-approval path for medical devices, the 510(k) process
Premarket notification (510k), Pt. i: ownership and licensing
- Hodgson Russ LLP
- -
- USA
- -
- March 21 2011
We are often asked by our clients about the transfer of the FDA marketing approvals from one entity to another
Premarket notification (510k), Pt. II: transfer
- Hodgson Russ LLP
- -
- USA
- -
- March 24 2011
A 510(k) may be bought, sold, or transferred
Regulatory pathway dilemma: avoiding a costly mistake
- Hodgson Russ LLP
- -
- USA
- -
- June 10 2011
You and your regulatory and technical team think the regulatory path for your medical device should either be exemption from the market approval or, at most, a Premarket Notification (510k
Labeling, advertising, and promotion of medical products
- Hodgson Russ LLP
- -
- USA
- -
- April 9 2012
Proper labeling of products regulated by the FDA is extremely crucial
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- Firm Name - Hodgson Russ LLP
- Workarea - Healthcare
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