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With rose colored glasses, I hope that FDA's case for quality - which is moving forward - limits this. ------------------------------ Michael Nilo Network Regulatory Partners Portland OR United States ------------------------------

Richard, similarly do you know if a HUD or Orphan Product (specifically for pediatrics) exists for Health Canada? Thanks, Mike ------------------------------ Michael Nilo Network Regulatory Partners Portland OR United States ------------------------------

Jinali, Richard's response is correct. You should fill out the CDRH Cover Sheet Form 3514. The submission # will be KXXXXXX/A001. Then just draft a cover letter ​on company letterhead that designates the new contact. I agree with Richard, "If you are corresponding to the reviewer via email, they may ...

Okay, By the letter of the law, industry does not need to follow draft guidances, nor should they be held to standards in draft guidances. In reality, draft guidances were written by the FDA and often reflect how they want things to go. Reviewers will try to hold companies to that standard even ...

Hello, I have not heard of the pilot program, but I am aware of the FDAs attempt to separate substantive review questions from the RTA administrative questions. This is a good thing and it provides you early insight into the FDA's thoughts. My strategy, assuming the substantive questions will take ...