Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers

Description

This guidance is intended to clarify Agency expectations regarding facility information that should be included in original new drug application(s) (NDA); abbreviated new drug application(s) (ANDA); original biologics license application(s) (BLA); amendments; supplements; chemistry, manufacturing, and controls (CMC) supplements; and resubmissions to these submission types. Submission of Form FDA 356h fulfills the requirement for applicants to submit an application form (21 CFR 314.50(a) and 314.94(a)(1); 601.2(a)). Form FDA 356h serves as both a summary of administrative information, as well as a repository of complete information on the locations of all manufacturing, packaging, and control sites for both drug substance and drug product facilities associated with the application. This guidance addresses questions related to the inclusion and withdrawal of proposed commercial facilities and development facilities, the appropriate location within an application for facility information, and the type of facility information that should be included in applications. Applications that include appropriate and complete facility information in the establishment information section of Form FDA 356h will reduce the frequency of Information Request (IR), Refusal to File (RTF), and Refuse to Receive (RTR) actions and increase the efficiency of the application assessment process. This guidance describes the recommended placement of all facility information for both original and supplement applications.

Scope & Applicability

• 21CFR314.50§ 314.50 Content and format of an NDA.

  NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →

• 21CFR211.84§ 211.84 Testing and approval or rejection of components, drug product containers, and closures.

  (a) Each lot of components, drug product containers, and closures shall be withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit.Read full regulation →

• 21CFR314.94§ 314.94 Content and format of an ANDA.

  ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →

• 21CFR601.2§ 601.2 Applications for biologics licenses; procedures for filing.

  (a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing aRead full regulation →

• 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.

  (a) Changes to an approved NDA.Read full regulation →

• 21CFR601.12§ 601.12 Changes to an approved application.

  (a) General.Read full regulation →

• 21CFR207.21§ 207.21 When must initial registration information be provided?

  (a) Registrants must register each domestic establishment no later than 5 calendar days after beginning to manufacture, repack, relabel, or salvage a drug or an animal feed bearing or containing a new animal drug at such establishment.Read full regulation →

• 21CFR4.4§ 4.4 How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?

  (a) Under this subpart, for single entity or co-packaged combination products, compliance with all applicable current good manufacturing practice requirements for the combination product shall be achieved through the design and implementation of a current good manufacturing practice operating systemRead full regulation →

• CGMP/Finished Pharmaceuticals/Adulterated

  SV Labs Corporation

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Guangdong Renhe Guozhuang Biotechnology Co., Ltd.

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Medinatura New Mexico, Inc.

  2025-12-23

• CGMP/Finished Pharmaceuticals/Adulterated

  Sklar Personal Care Inc.

  2025-12-16

• CGMP/Deviations/Biologics License Application (BLA)

  Microvascular Tissue, Inc.

  2025-12-16

• CGMP/Finished Pharmaceuticals/Adulterated

  Catalent Indiana, LLC

  2025-12-11

• CGMP/Finished Pharmaceuticals/Adulterated

  DeVere Manufacturing Inc.

  2025-12-09

• CGMP/Finished Pharmaceuticals/Adulterated

  CDL Services, Inc. DBA Technichem

  2025-12-09

• CGMP/Finished Pharmaceuticals/Adulterated

  Seaway Pharma Inc.

  2025-12-09

• CGMP/QSR/Medical Devices/Adulterated

  Envoy Medical Inc.

  2025-12-09

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