answersLogoWhite

0

There is no fixed limit to the number of pre-IND meetings you can have with the FDA. Sponsors may request multiple meetings if needed, especially if significant new information arises or if there are major changes to the development plan. However, it's advisable to use these meetings judiciously and to come prepared to make the most of each session. The FDA typically encourages open dialogue but may also provide guidance on whether additional meetings are necessary.

User Avatar

AnswerBot

2mo ago

What else can I help you with?

Related Questions

Is Great Value products approved by FDA?

The FDA approves Drugs. Food is not "Approved" it is monitored and regulated by the FDA. I could not find any "Drug" products under the generic WallMart brand GREAT VALUE, If there are some they are approved.


Does the FDA mandate that cosmetics be tested on animals prior to release on the market?

The FDA does not require anything to be tested on animals. However, many, many companies still choose to do so.


What are FDA approved rosacea treatments?

While there are many rosacea treatments available on the market, not all of them are approved by the FDA. Two of the most popular FDA approved rosacea treatments are Obagi Rosaclear and Oracea, which is taken orally.


Is garcinia cambogia fda approved?

Garcinia cambogia, like many herbal and natural remedies, is not FDA approved and should be used with caution and not in large quantities.


How many layers of skin do human have does fda think?

3 layers


Which is not regulated by the FDA?

SANDwiches are not regulated by the FDA.


Why does the FDA allow chemo and many other prescription drugs that can cause cancer and cause your DNA to be changed to cause you more illness to be allowed by the FDA?

You're an idiot.


What is FDA drug rating?

what is FDA drug rating


What does and FDA consultant do?

"An FDA consultant is basically an extension of the FDA, helping companies meet the regulations set forth by the FDA." An FDA consultant is just someone that makes sure your company is adhering to Food and Drug Admin. Standards.


Is Juice Plus plus FDA approved?

YES!!!!!! it's FDA approved and it's approved by the global FDA


What do the FDA govern in the USA?

Poorly! When a drug company comes up with a new drug many studies and trials must be done on the drug first and then passed by the FDA. Lately it appears the FDA is not doing their job!


Have weight loss patches been tested and approved by the FDA?

The FDA does not approve of weight loss patches, and many evidence shows that they are ineffective. There are still companies out there that claim to be approved, this is not true.