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May 12, 2021

Devices Used to Process Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Docket Number: FDA-2020-D-1407 Issued by: Guidance Issuing Office Office of the Commissioner,Office of Clinical Policy and Programs,Office of Combination Products For questions regarding this document, contact:Office […]
May 12, 2021

Early Development Considerations for Innovative Combination Products

Docket Number: FDA-2020-D-1455 Issued by: Guidance Issuing Office Office of the Commissioner,Office of Clinical Policy and Programs,Office of Combination Products For questions regarding this document, contact: […]
May 12, 2021

Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product

Docket Number: FDA-2004-D-0502 Issued by: Guidance Issuing Office Office of the Commissioner,Office of Clinical Policy and Programs,Office of Combination Products   Additional copies of this guidance […]
May 12, 2021

Application User Fees for Combination Products

Docket Number: FDA-2004-D-0371 Issued by: Guidance Issuing Office Office of the Commissioner,Office of Clinical Policy and Programs,Office of Combination Products For questions regarding this document, contact: […]
May 12, 2021

How to Write a Request for Designation (RFD)

Docket Number: FDA-2011-D-0214 Issued by: Guidance Issuing Office Office of the Commissioner,Office of Clinical Policy and Programs,Office of Combination Products For questions regarding this document, contact:Office […]
May 12, 2021

Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4

Docket Number: FDA-2013-D-0362 Issued by: Guidance Issuing Office Office of the Commissioner,Office of Clinical Policy and Programs,Office of Combination Products This guidance document is being distributed […]
May 12, 2021

Environmental Impact Statement (EIS) for Certain Sunscreen Drug Products​

The following information relates to FDA’s Environmental Impact Statement (EIS) for Certain Sunscreen Drug Products for over-the-counter (OTC) use.  FDA has published in the Federal Register […]
May 11, 2021

C&G Laboratorios SA de CV – 610782 – 04/26/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Yoshua Rostenberg Recipient Title Legal Representative C&G Laboratorios SA de CV Pestalozzi No. 415, Navarte03020 Benito […]
May 11, 2021

Qualified Infectious Disease Product Designation Questions and Answers

Docket Number: FDA-2017-D-7001 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance provides information to sponsors about FDA’s implementation of Title VIII […]
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