This week FDA finalized its draft guidance on Controlled Correspondence Related to Generic Drug Development. Although all submitted comments were considered, FDA’s revised the draft to “provide clarifying and explanatory information that will assist human generic drug manufacturers and related industry as they submit controlled correspondence to FDA.” The following additions were included in the final guidance:
Additionally, the guidance excluded three types of inquiries that will continue to be treated differently from other generic drug development inquiries even though they technically fall under the definition of controlled correspondence. These include: “(1) requests for recommendations on the appropriate design of BE studies for a specific drug product (BE guidance requests); (2) requests for review of BE clinical protocols (clinical protocol requests); and (3) requests for meetings to discuss generic drug development prior to ANDA submission (pre-ANDA meeting requests).”
October 2, 2015
After the FDA passed the Orphan Drug Act in 1983, the number of orphan drugs (drugs indicated for the treatment of rare diseases that affect 200,000 people or less in the United States) submitted to...
October 2, 2015
Additional information on FDA’s recommendations for interoperable medical devices is available in our blog post entitled “A Closer Look at FDA’s Draft Guidance Regarding Premarket Submissions for...
October 2, 2015
On Tuesday, February 19th, FDA published a draft guidance for medical device makers which identifies a process for companies to request nonbinding feedback on certain FDA Form 483 deficiencies noted...