Newsletter - January 7, 2021
FDA Raises Important Confidentiality Warning in a New Guidance Document
In the first Guidance Document of 2021, FDA emphasized a very important procedural aspect of sponsor-FDA meetings arising from the sponsor inviting outside parties to such meetings. FDA warns that bringing an outside party to a sponsor-FDA meeting could potentially compromise the confidentiality of the information discussed.....Read More
FDA Issues Year-End Warning Letters to CBD Product Manufacturers, Again
Just before Christmas, FDA issues several Warning Letters to manufacturers of CBD products for making drug like claims. These included products intended for risky route of administration such as nasal, ophthalmic and inhalation. All the products for which Warning Letters were issued technically sold CBD products as dietary supplements ....Read More
FDA Raises Important Confidentiality Warning in a New Guidance Document
In the first Guidance Document of 2021, FDA emphasized a very important procedural aspect of sponsor-FDA meetings arising from the sponsor inviting outside parties to such meetings. FDA warns that bringing an outside party to a sponsor-FDA meeting could potentially compromise the confidentiality of the information discussed.....Read More
FDA Issues Year-End Warning Letters to CBD Product Manufacturers, Again
Just before Christmas, FDA issues several Warning Letters to manufacturers of CBD products for making drug like claims. These included products intended for risky route of administration such as nasal, ophthalmic and inhalation. All the products for which Warning Letters were issued technically sold CBD products as dietary supplements ....Read More
