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Dear Experts, To fulfil the requirement of ANDA Submissions -Content and Format guidance from FDA we are providing below documents in 3.2.P.8 sections - 3.2.P.8.1 Contains the stability summary and ...
Submission of applications to the Japanese authority now mandates usability engineering. The international standard IEC 62366-1, governing usability engineering in medical device development, transitioned ...
Join Novotech for a CTIS webinar. Ensure a seamless transition and compliance by January 2025! Regulatory Affairs Professionals Society (RAPS) San Francisco Bay Chapter is honored to be invited to participate ...
This message was posted by a user wishing to remain anonymous Hello, everyone, I am seeking insights or experiences from peers who might have dealt with a similar situation. We currently sell our medical ...
This message was posted by a user wishing to remain anonymous Thank you so much for your insights. Your clarification is especially helpful. Best regards,
This message was posted by a user wishing to remain anonymous Thanks Richard. Any insights on the 2nd part of the question? If a company fails to answer/address the deficiency within the 180-days once ...
Submission of applications to the Japanese authority now mandates usability engineering. The international standard IEC 62366-1, governing usability engineering ... More
Join Novotech for a CTIS webinar. Ensure a seamless transition and compliance by January 2025! Regulatory Affairs Professionals Society (RAPS) ... More
Join Women In Bio Capital Region and the University of Maryland School of Pharmacy for an exploration of strategies aimed at risk mitigation, implementation, ... More
This message was posted by a user wishing to remain anonymous Hello, everyone, I am seeking insights or experiences from peers who might have dealt ... More
This message was posted by a user wishing to remain anonymous Hi! I've been struggling with the following consideration: For Section 3.2.P.1 for ... More
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