Newsletter - June 21, 2018
FDA Allows Off-Label Promotion, Sort of.
In two new Guidance documents released this week, FDA presents a detailed explanation of its requirements for advertisement of approved products. In a slight policy shift, FDA walks away from the rigid enforcement of approved labels and provides some flexibility in marketing communications, while maintaining its control over new uses of approved products. Read More
FDA Fee Waivers, Refunds and Reductions: Apply within 4-6 months of Need
FDA charges fees for most market approval applications but grants waivers to a lot of applicants based on various criteria. A new Guidance document released this week, discusses all the various ways the fees can be reduced or waived by the FDA. In case the applicant has already paid the fee....Read more
FDA Allows Off-Label Promotion, Sort of.
In two new Guidance documents released this week, FDA presents a detailed explanation of its requirements for advertisement of approved products. In a slight policy shift, FDA walks away from the rigid enforcement of approved labels and provides some flexibility in marketing communications, while maintaining its control over new uses of approved products. Read More
FDA Fee Waivers, Refunds and Reductions: Apply within 4-6 months of Need
FDA charges fees for most market approval applications but grants waivers to a lot of applicants based on various criteria. A new Guidance document released this week, discusses all the various ways the fees can be reduced or waived by the FDA. In case the applicant has already paid the fee....Read more
