Cover letter attachments for controlled correspondence and ANDA submissions: guidance for industry
- Collection:
- Health Policy and Services Research
- Contributor(s):
- Center for Drug Evaluation and Research (U.S.), issuing body.
- Publication:
- Silver Spring, MD : Center for Drug Evaluation and Research, June 2023
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Correspondence as Topic Drug Approval Drug Industry Drugs, Generic Government Regulation United States United States. Food and Drug Administration
- Genre(s):
- Guideline Technical Report
- Abstract:
- This guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications (ANDAs) with optional attachments that can be used when preparing cover letters that accompany controlled correspondence, original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA. These attachments do not replace the recommendations for the content of cover letters provided in other FDA guidances. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (18 pages))
- NLM Unique ID:
- 9918662583306676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918662583306676