Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule - PubMed

• PMID: 18958946

Free article

Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule

Food and Drug Administration, HHS. Fed Regist. 2008.

Free article

Abstract

The Food and Drug Administration (FDA) is amending its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA). This final rule provides that a supplemental application submitted under certain FDA regulations is appropriate to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the drug, biologic, or device, as defined in other FDA regulations and guidance documents.

Similar articles

• Requirements for submission of labeling for human prescription drugs and biologics in electronic format. Final rule.

  Food and Drug Administration, HHS. Food and Drug Administration, HHS. Fed Regist. 2003 Dec 11;68(238):69009-20. Fed Regist. 2003. PMID: 14672084

• Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices--FDA. Final rule.

  [No authors listed] [No authors listed] Fed Regist. 1998 Nov 20;63(224):64556-88. Fed Regist. 1998. PMID: 10339052

• Applications for approval to market a new drug; complete response letter; amendments to unapproved applications. Final rule.

  Food and Drug Administration, HHS. Food and Drug Administration, HHS. Fed Regist. 2008 Jul 10;73(133):39588-611. Fed Regist. 2008. PMID: 18850675

• Making sense of the food and drug administration.

  Connor JA. Connor JA. Semin Pediatr Surg. 2006 Nov;15(4):293-301. doi: 10.1053/j.sempedsurg.2006.07.009. Semin Pediatr Surg. 2006. PMID: 17055960 Review.

• Drugs and other product choices.

  Hyman PM, Carvajal R. Hyman PM, et al. Dermatol Ther. 2009 May-Jun;22(3):216-24. doi: 10.1111/j.1529-8019.2009.01234.x. Dermatol Ther. 2009. PMID: 19453345 Review.

Cited by

• Don't sell out safety: a call to preserve risk evaluation and mitigation strategies to reduce harm to patients and the public in the U.S.

  Worthy SL. Worthy SL. J Pharm Policy Pract. 2016 Jan 21;9:2. doi: 10.1186/s40545-016-0051-0. eCollection 2016. J Pharm Policy Pract. 2016. PMID: 26798484 Free PMC article.

• Challenges and Opportunities to Updating Prescribing Information for Longstanding Oncology Drugs.

  Balogh EP, Bindman AB, Eckhardt SG, Halabi S, Harvey RD, Jaiyesimi I, Miksad R, Moses HL, Nass SJ, Schilsky RL, Sun S, Torrente JM, Warren KE. Balogh EP, et al. Oncologist. 2020 Mar;25(3):e405-e411. doi: 10.1634/theoncologist.2019-0698. Epub 2019 Dec 8. Oncologist. 2020. PMID: 32162805 Free PMC article.

• Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings.

  Cook DM, Gurugubelli RK, Bero LA. Cook DM, et al. Drug Saf. 2009;32(11):1057-66. doi: 10.2165/11316670-000000000-00000. Drug Saf. 2009. PMID: 19810777

MeSH terms

Substances