The FDA Law Blog
MAY 11, 2023
GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”
pharmaphorum
MAY 25, 2022
“Where it is impossible to restrict access to HCPs, due to the congress platform or equivalent, there must be a clear statement to the attendee that the materials/communication are designed and intended for HCPs only.”. Here, we take a look at the top five takeaways from the document: 1. Identifying the appropriate code and label.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
The FDA Law Blog
JUNE 27, 2023
FDA also requests a “detailed description of the allegation with any available supporting documentation.” In our experience, the more detailed the documentation that accompanies the submission, the more likely FDA will follow-up on the submission. There are drawbacks to the current communication channels: 1.)
The Checkup by Singlecare
APRIL 5, 2024
That’s because the Food and Drug Administration (FDA) has approved it for Type 2 diabetes , while weight management is technically an off-label treatment. Foxman recommends that every patient review their formulary to see how Ozempic is covered and communicate directly with their insurer for clarity on the specific requirements. “It’s
The FDA Law Blog
APRIL 25, 2023
The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers. Loose Ends IDEs.
pharmaphorum
OCTOBER 27, 2022
The overarching principle set out in Codes of Practice, and in particular the Principles for the use of digital channels in the EFPIA Code , is that the legislation and Codes of Practice apply equally to communications by companies on social media and digital channels.
The FDA Law Blog
JULY 10, 2023
FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. When referencing documents within the AI response, cite location within the 510(k) supplement (e.g.,
Expert insights. Personalized for you.
72 
Let's personalize your content