Sounds just like a doctor. Advice, no treatment that heals.

Amazing presentation

Loved this talk though. Studying as part of an informatics course

Since it costs millions or even billions to bring de novo medicines to market, FDA does care and charge for its services. For example, it costs btw $873k to $1.7million for an application fee for biosimilar medications. This is among other charges. Outside of research and drug trials it's best to team with well established companies to bring de novo treatments to market.

You made a public threat in which compromises my home security. And because you profusely lied about me for so many years across the whole internet, it is my safety and constitutional rights that require full disclosure. I've done nothing to threaten you Masha, which means that you initiated this with the recommended videos about "Russian surveillance in my home" yesterday. You did this and not me, I am only responding to that threat. Fair is fair Masha, I've never threatened you. This must be repaired Masha or it will never end. I know that you want me "ruined in life" because you don't want to admit that you messed up, but you don't have that luxury Masha. I have the right to a future too. You need to provide disclosure Masha out of fairness. Daniel

Clear information and voice. Thank you!

I was wondering if you had any plans on discussing the Target Candidate Profile as well?

FDA is "Food" and Drug Administration (a federal agency)

Hey! This video is informative! I have been trying to search for a vid similar to yours that really explains everything in this KZbin video. 🧑‍⚕️ 👌Your breakdown is like the channel from Dr. Ethan! Ethan's demonstrations are insightful and I actually learned a lot for midterms! He is a cool med student! Go check out his YT out and give Doctor Ethan a subscribe! 👉 #DrEthanVideos

This was instructional. I have been trying to research for a KZbin vid that really informs the stuff in this KZbin video! 🩺Your lesson really is like the videos from this smart health enthusiast Doctor Ethan. Dr's demonstrations are really informative and I actually learned a lot for my midterms! He is a knowledgable health enthusiast! You should check out his channel out and give the Doctor a like here! 👉 #FutureDrEthan

Detailed explanation on 510k and tips on submitting and getting approval!

very good information for practicing NDA

Can anyone have one

Great video! I have to aks you. Do you think it is necessary to have an NDA if I want to wire a freelancer to write my description for my book, he/she will get my book so they can read it. What kind of NDA should I have, if it is necessary? Thank you

I really appreciate this video because informative and I learn a lot about protecting my ideas and making lots of money.

Thanks for sharing great lectures.

Quick, detailed, and helpful information.

I'm curious how 300k to a million for initial costs on a class 1 device breaks down, budget wise

good too know thank you very informative

Great presentation, thanks so much. This is very helpful.

Skip to 2:30 minute. Ur welcome.

Great video ! thanks a lot

In 510k, the product gets cleared by USFDA but you mentioned as approved? please clarify sir

The FDA has recalled a common drug used to treat heart conditions after it was found to contain a chemical linked to cancer. Read Full Article Here bit.ly/2Ll3bSR

www.emprd.com for plastic medical devices development, plastic medical mould development, low-volume manufacturing, CFDA registration, etc

Great presentation, thank you! I used it to help study for my bioregulations exam. Super helpful.

I hope you will translate the videos to Arabic😊

CFR = Code of Federal Regulations

If I would like to make a MDDS system. What do i acctely have to do. If i understand correct it is a class 1. It is a shared data with a video conframce with and added DICOM viewer more or less.. It would not be to view a live operation but for viewing a case before operations and so on.. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm243283.htm www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=880.6310

It's a very informative presentation. Thank you very much for uploading it.

Very informative. Can you please give me the link to part 2?

Hi, Thank you for the Video