2015 Individual IT Manufacturing 
FDA Law Blog
AUGUST 26, 2021
In its Compliance Guidance for Pharmaceutical Manufacturers , the HHS OIG notes: The OIG recognizes that the implementation of a compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer.
FDA Law Blog
NOVEMBER 1, 2023
Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers.
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FDA Law Blog
FEBRUARY 21, 2024
It is intended to reduce regulatory burdens on medical device manufacturers and importers by enhancing global harmonization in device regulation. It also specifies that manufacturers document the Unique Device Identifier (UDI) for each medical device or batch of medical devices in accordance with Part 830, Unique Device Identification.
FDA Law Blog
JANUARY 26, 2022
In defending the complete broadcast, Lilly called out similar elements from each of the individual components as demonstrating its intent to have all three viewed sequentially. By Dara Katcher Levy — We are working to keep up with OPDP’s posts over the past few weeks and a blog on its most recent letter to Lilly is forthcoming!
FDA Law Blog
OCTOBER 5, 2022
In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. The healthy claim has been the topic of much discussion and challenged in consumer class actions.
FDA Law Blog
DECEMBER 18, 2022
Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. FDA began an initial VMSR pilot program in 2015. The draft guidance sets forth a process for doing so.
GeriPal
MARCH 2, 2023
By 2015 that number increased to 4% of US adults. In 2002, 1% of adults were taking gabapentinoids (gabapentin and or pregabalin). There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. Tasce: I do. Tasce: Yes. Eric: Yeah.
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