21 C.F.R. § 314.98
Postmarketing reports
(a) Each applicant having an approved abbreviated new drug application under § 314.94 that is effective must comply with the requirements of § 314.80 regarding the reporting and recordkeeping of adverse drug experiences.
(b) Each applicant must make the reports required under § 314.81 and section 505(k) of the Federal Food, Drug, and Cosmetic Act for each of its approved abbreviated applications.
Notes of Decisions
Cited in 11
cases, 2009–2020 · leading case: Gaeta v. Perrigo Pharm. Co., 630 F.3d 1225 (9th Cir. 2011).
Gaeta v. Perrigo Pharm. Co., 630 F.3d 1225 (9th Cir. 2011). “80 (a), (c) (NDA holders); 21 C.F.R. § 314.98 (a) (ANDA holders). Similarly, both sets of manufacturers must submit annual reports that include, inter alia, a “brief summary of significant new information from the previous year that might affect the safety, effectiveness, or…”
Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009). “Further, 21 C.F.R. § 314.98 requires that generic manufacturers follow the same record keeping and reporting of adverse drug experiences post marketing that name brand manufacturers must undertake.”
Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279 (D.N.H. 2009). “at 17983 (codified as amended at 21 C.F.R. § 314.98 (a)). Section 314.80 requires an applicant to report (A) “each adverse drug experience that is both serious and unexpected .”
Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010). “57(c)(6) (explaining that evidence must be "reasonable” in order to change a label's warnings and precautions); Id. at § 201.57(c)(7) (explaining that there must be "some basis to believe” in order to change a label's discussion of adverse reactions).”
Bartlett v. Mut. Pharm. Co., Inc., 731 F. Supp. 2d 135 (D.N.H. 2010). “80 (b), which requires brand-name drug manufacturers to “develop written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences to FDA,” applies equally to generic drug manufacturers by virtue of 21 C.F.R. § 314.98 (a),…”
Fulgenzi v. Wyeth, Inc., 686 F. Supp. 2d 715 (N.D. Ohio 2010). “at 609 (citing 21 C.F.R. § 314.98 ). It further drew from the FDA's own comment noting that "ANDA applicants [must] submit a periodic report of adverse drug experiences even if the ANDA applicant has not received any adverse drug experience reports or initiated any labeling…”
Bartlett v. Mut. Pharm., 2010 DNH 112 (D.N.H. 2010). “80 (b), which reguires brand-name drug manufacturers to "develop written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences to FDA," applies egually to generic drug manufacturers by virtue of 21 C.”
Wyeth, Inc. v. Danny Weeks & Vicki Weeks, 159 So. 3d 649 (Ala. 2014). “21 C.F.R. § 314.98 . However, brand-name manufacturers and generic manufacturers have different federal drug-labeling responsibilities.”
Bartlett v. Mut. Pharm., 2009 DNH 144 (D.N.H. 2009). “at 17983 (codified as amended at 21 C.F.R. § 314.98 (a)). Section 314.80 requires an applicant to report (A) “each adverse drug experience that is both serious and unexpected .”
Raymond J Collette v. Wyeth Pharm., Inc. (N.D. Cal. 2020). “80 (c); 21 C.F.R. § 314.98 ). The fifth cause of action alleges 16 “strict liability – manufacturing defect,” and is based on allegations that “the Manufacturer 17 Defendants failed to comply with the FDA’s Good Manufacturing Practices with regard to 18 Packaging and Labeling…”
Gladys Mensing v. Wyeth, Inc. (8th Cir. 2009). “Further, 21 C.F.R. § 314.98 requires that generic manufacturers follow the same record keeping and reporting of adverse drug experiences post marketing that name brand manufacturers must undertake.”
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