Post by mnholdem on Nov 16, 2016 14:58:25 GMT -5
A number of statements have been posted in recent weeks that suggest MannKind has not submitted any application for label change to the FDA, so I made a simple email query to learn whether this information is available to the general public. In response to my email inquiry FDA/CDER replied this morning with the following information:
November 16, 2016 11:24AM
Dear [Sir],
Thank you for writing to the Division of Drug Information, Small Business and Industry Assistance (SBIA), in the FDA's Center for Drug Evaluation and Research (CDER).
Please be advised that we do not provide a site where “you can search for information related to drug APPLICATIONS/SUBMITTALS for any drug label changes that are currently being reviewed” since information regarding an application under review is considered confidential and can only be disclosed directly to the drug sponsor as per 21 CFR 314.430.
Once the application has been approved, you may obtain updated labeling from our Drug Safety Labeling Changes (SLC) database which provides approved safety labeling changes from January 2016 forward. Data prior to January 2016 will continue to be available on the MedWatch website. To learn more about SLC, please visit www.fda.gov/Drugs/DrugSafety/ucm517519.htm.
In addition to the SLC database, you may also obtain current labeling for FDA-approved drugs from our database Drugs@FDA: FDA Approved Drug Products. Alternatively, you may also search the DailyMed database for drug labeling, which includes both FDA-approved and “unapproved” drugs.
If in the future you have additional questions, please feel free to contact us again at CDERSBIA@fda.hhs.gov.
Best regards,
KDe
Drug Information Specialist
CDER Small Business and Industry Assistance
Division of Drug Information
Center for Drug Evaluation and Research
Food and Drug Administration
Follow CDER SBIA on LinkedIn
CDER has made it easier for small business to interact with the Agency via our Small Business Assistance and Industry Assistance contacts:
E-mail: CDERSBIA@fda.hhs.gov
Phone: (866).405.5367 or (301).796.6707
Website: www.fda.gov/CDERSBIA
CDER Small Business survey: www.surveymonkey.com/s/CDERSBIA_Evaluation
For up-to-date drug information, follow the FDA's Division of Drug Information on Twitter at FDA_Drug_Info
This communication is consistent with 21 CFR 10.85(k) and constitutes an informal communication that represents our best judgment at this time but does not constitute an advisory opinion, does not necessarily represent the formal position of the FDA, and does not bind or otherwise obligate or commit the agency to the views expressed.
