Recently Issued Guidance Documents

Should you find a Web link (URL) embedded within guidance documents that does not work or other documents posted on the FDA Web site, please try searching for the document using the document title. If you need further assistance, please go to Contact FDA.

---

• Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers; Guidance for Industry
  CDER/CBER, June 2021

• Enhanced Drug Distribution Security at the Package Level under the Drug Supply Chain Security Act; Draft Guidance for Industry
  CDER/CBER, June 2021

• Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act; Draft Guidance for Industry
  CDER/CBER, June 2021

• Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification; Guidance for Industry
  CDER/CBER/ORA, June 2021

• Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry
  (Updated May 25, 2021) CBER, May 2021

• Bispecific Antibody Development Programs; Guidance for Industry
  CDER/CBER, May 2021

• Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products; Draft Guidance for Industry
  CDER/CBER, May 2021

• Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1); Draft Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1)
  CDER/CBER/OGCP, May 2021

• Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection, and Withdrawal of Guidance titled “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components”
  CBER, May 2021

• COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers; Guidance for Industry
  CDER/CBER, March 2021

• Investigational COVID-19 Convalescent Plasma; Guidance for Industry
  (Updated February 11, 2021)  CBER, February 2021