FDA also provides additional information on PMRs under the Pediatric Research Equity Act and Accelerated Approval programs.Reporting serious adverse events (“SAEs”) that occur with an approved drug being used in clinical practice for treatment of COVID-19, when the sponsor also has an IND application for the same drug being investigated to treat COVID-19. FDA advises that (1) SAEs that occur in clinical practice must be reported in accordance with applicable postmarketing reporting requirements (see e.g. 21 CFR § 314.80 and § 600.80), (2) SAEs that occur during a clinical trial under an IND for an approved drug or biological product being investigated for a new use must be reported as an IND safety report per 21 CFR § 312.32 if they are unexpected and the sponsor determines that there is a reasonable possibly that the drug caused the SAE, and (3) regardless of its source, if safety information indicates a new serious risk associated with a drug under investigation, the sponsor will need to file an IND safety report with FDA, and updates likely will need to be made to the investigator brochure and/or the informed consent document.Reporting of SAEs associated with COVID-19 diagnosis in non-COVID 19 trials. FDA advises that a sponsor must report an SAE that is both unexpected and for which there is a reasonable possibility that the drug caused the SAE. FDA notes that it is possible that an investigational drug might be causally related to a SAE associated with COVID-19 by making subjects in the trial mo

com, stuart@paynterlaw.com, and cboyd@paynterlaw.com.Notes1 See, e.g., 21 C.F.R. §§803.1 et seq. (2015) (medical device reporting); 21 C.F.R. §310.305 (2015) (adverse event reporting for certain new drugs); 21 C.F.R. §312.32 (2011) (safety reports for investigational new drugs); 21 C.F.R. §314.80 (2015) (postmarket reporting of adverse drug experiences).2 Aircraft carriers and nuclear power plants are two examples of high reliability organizations—both engage in extremely risky activities yet maintain nearly error-free operations, showing that it’s possible to manage even very high-risk activities.3 Ingham v. Johnson & Johnson, 2018 WL 3493335 (Mo. Cir. Ct. July 12, 2018); see also Lisa Girion, Johnson & Johnson Knew for Decades That Asbestos Lurked in Its Baby Powder, Reuters (Dec. 14, 2018).4 Compare, e.g., O’Brien v. Cessna Aircraft Co., 298 Neb. 109, 139 (Neb. 2017) (“[P]unitive, vindictive, or exemplary damages . . . are not allowed in [Nebraska].”

As defined by both bills, this would include adverse events associated with the use of a cosmetic product, ranging from disfigurement to death. This is similar to the existing mandatory reporting requirement for drugs, see 21 C.F.R. § 314.80(c)(1), but adverse event reporting is currently voluntary for cosmetics. The Feinstein‑Collins bill also includes an annual report requirement, under which companies would have to submit to the FDA a yearly report summarizing all adverse events for each cosmetic product marketed during that year.Registration of cosmetics facilities.

Accordingly, the fraud claims are preempted.Id.Other FDCA-Related Issues On other FDCA-related issues, Utts II ends up on our Adverse Drug/Device Event cheat sheet because of its discussion of how voluntarily reported adverse events aren’t legitimate proof of causation: Federal regulations advise that a report submitted by a manufacturer “does not necessarily reflect a conclusion by the [manufacturer] or FDA that the report or information constitutes an admission that the drug caused or contributed to an adverse effect.” 21 C.F.R. § 314.80(l). As the FDA Website explains: FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event.

Manufacturers are to submit their FARs via Form 3331. Also, in contrast to postmarket adverse drug experience reporting under 21 CFR 314.80, FARs potentially involve one of a variety of drug quality issues that could be of interest or concern to both the field office and CDER.According to the Compliance Program Guidance Manual 7356.021 (CPG), which was updated within the past year and upon which much of the information below is based, the three working days begins when the applicant becomes aware of a problem either through a complaint or internal testing, such as during stability testing or testing of reserve samples. It does not begin the day that the applicant confirms or invalidates a problem.

The warning letters relate to certain observations that the FDA believes were inadequately addressed by the companies’ response to Form 483s. The FDA issued the warning letters for violations of Postmarketing Adverse Drug Experience (PADE) reporting requirements under section 505(k) of the Federal Food, Drug, and Cosmetic Act and Title 21, Code of Federal Regulations 314.80 and 314.98, including failures to submit Periodic Adverse Drug Experience Reports (PADERs).

[4] 21 U.S.C. §355(d)(1)-(4), (7); 21 CFR §314.50(c)(2)(i).[5] 21 CFR §314.80(b)-(c); see generally 21 U.S.C. §355(k)(1) (authorizing FDA to require reports of clinical experience with approved drugs).[6] 21 U.S.C. §355(o)(4).