It's shocking to learn that the home remedy you've been preparing, using and selling to people needs to be regulated by the FDA as a drug. Because the remedy helps people, you may be very interested in FDA approval but be unaware of how to proceed without legal problems and other trouble. Take care with these tasks and actions; not only could they affect your approval and pocketbook, but lives as well.
Pull the Product
If you've indeed been selling your home remedy, it's probably wise to do a full cease and desist during this time. You don't want to risk anyone's health, nor do you want to be subject to lawsuits about your product while you're working so hard to be approved.
Do FDA-compliant Testing
While you may have tweaked your remedy and tried out different combinations of ingredients due to comments or complaints from others, the FDA will require that you do a great deal more testing than that. The primary concern of the FDA is that your home remedy works and that any side effects don't overshadow its benefits. They are likely to require a lengthy study in order for you to best prove that claims you make are true and that the product works.
Because their requirements do shift slightly from time to time, contact the FDA directly to know what studies they require.
Complete All Paperwork
You may think filling out documents is easy, but when you're working with any government agency they may ask for more information than you expect and it can be unclear what exactly they need. Leaving spaces blank or making notes about what will be submitted later isn't the best way to handle this paperwork; mistakes here can cause a delay of months and even years.
Seek Assistance from Regulatory Affairs Services
Even when you're doing things properly, FDA approval can take time and be stressful as you await news. That's why you should strongly consider bringing in consultants with regulatory affairs service experience. Because they know the process, they can answer questions and give you ideas which could make your application more successful. Their help can demystify the process and enable you to take each step with more confidence.
Working to have your home remedy approved by the prestigious FDA takes time, commitment and a lot of patience. Get expert help and use this information to finally make it happen. Contact local regulatory affair services for more information and assistance.
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