The ARRIVE guidelines (Animal Research: Reporting of In Vivo Experiments) are a checklist of information to include in publications describing animal research.

The process of drug development involves non-clinical and clinical studies. Non-clinical studies are conducted using different protocols including animal studies, which mostly follow the Good Laboratory Practice (GLP) regulations. During the early pre-clinical ...

"Section 401 of FDAMA19 described certain conditions under which a drug or medical device manufacturer could choose to disseminate medical and scientific information that discusses unapproved uses of approved drugs and cleared or approved medical devices to “health care professionals and certain entities, including pharmacy benefits managers, health insurance issuers, group health plans, and Federal or State governmental agencies,” without such dissemination being considered as evidence of the manufacturer’s intent that the product be used 99 for an unapproved new use. Among those conditions was the expectation that the manufacturer of the product would seek FDA approval for the unapproved new use referenced in the disseminated literature." "FDA recommends that manufacturers employ the following practices if they choose to disseminate scientific and medical publications that include or may include information on unapproved new uses of approved, cleared, or 510(k) exempt products." “it is unlawful for a manufacturer to introduce a drug into interstate commerce with an intent that it be used for an off-label purpose”

"If a firm responds to... unsolicited requests for off-label information in the manner described above, FDA does not intend to use such responses as evidence of the firm’s intent that its product be used for an unapproved or uncleared use. Such responses also would not be expected to comply with the disclosure requirements related to promotional labeling and advertising. "

"...if a firm communicates information that is not contained in its product’s FDA-required labeling but that is determined to be consistent... FDA does not intend to rely on that communication to establish a new intended use. " "Product communications that are consistent with a product’s FDA-required labeling but are false or misleading may subject a firm to enforcement action under the FD&C Act." "FDA views communications that do not trigger the need for a 510(k) to be consistent with the FDA-required labeling, and does not intend to rely on such communications to establish a new or significantly modified intended use, or one that is different from the use for which the product is legally marketed." "How does FDA determine whether a firm’s product communication is consistent with the FDA-required labeling?" ^Different indication; additional patients; conflict with limitations and directions for handling/use; conflict with dosing, use regimen, route administration, or strength^ ^not considered consistent: use of a product to treat different stage, severity, or manifestation of a disease than the product is approved to treat.^ "Therefore, FDA would not consider representations or suggestions in a CFL promotional communication to be false or misleading based only on the lack of evidence sufficient to satisfy the applicable approval/clearance standard." "...nformation should be presented in a way that does not overstate the conclusions that can be drawn from the supporting evidence."

"This labeling may pertain to therapeutic, restorative, diagnostic, or cosmetic devices."

"Interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc." "Most, if not all advertising, is labeling."

**** "Conflict with labeling means any deviation from instructions, requirements, or prohibitions of registered labeling concerning storage, handling, or use except those outlined below. ... The following exceptions do not apply to section 18 emergency exemptions." "When products with a specific active ingredient have been registered, those products cannot be used for any non-pesticide use that is not listed on the labeling."

"Do FIFRA 2(ee) recommendations generally include rate of application requirements or is the user bound by label directions? LC09-0276; 8.13.09. A FIFRA 2(ee) recommendation may be made for a number reasons, one being the application of the pesticide at less than the label dosage, concentration or frequency. An applicator may apply the product at the use dilution listed on the label or at a lesser use dilution listed in the 2(ee) recommendation. An applicator has the option of applying at less than the use dilution listed on the label unless the label specifically prohibits such dilution. Note that for antimicrobial pesticides targeted against human pathogens, it is unlawful for any person selling or distributing these products to advertise uses permitted by FIFRA 2(ee)" "Section 2(ee) allows the use of a pesticide against any target pest not specified on the labeling as long as the site is identified on the label and there are no other label restrictions that would preclude use against the pest." "Persons may not make claims under section 2(ee) for antimicrobial pesticide products targeted against microbial human pathogens."

Information about applying approved disinfectants for use against COVID-19.

"Pesticide application equipment that is sold separately from the pesticide itself is not a device or a pesticide." "The device may be “misbranded” if labels, labeling, and/or websites for devices including general or specific efficacy claims include any statement, design, or graphic representation that is “false or misleading in any particular.” "Also, please note that some state laws have requirements for devices in addition to those imposed by FIFRA. Some state governments require registration of devices, including submission and review of efficacy data and labeling, before a device can be sold or distributed"

Medical devices used to diagnose or treat COVID-19 include diagnostic tests, masks, gowns, gloves, sterilizers, and ventilators.

Answers to frequently asked questions about registration and listing of medical devices during the COVID-19 public health emergency

Sept 2019

{Includes info on premarket notification (510(k)) requirements}

Aug 2020

2013. Concerned that fogging/misting products may not be as effective as claimed, and we want to ensure that these fogging/misting products are accurately labeled. Request for efficacy data, or revision of claims.

Exempt from the effectiveness requirements of Sections 514 and 515 of the FD&C Act and is subject to certain profit and use restrictions.. The Humanitarian Device Exemption Program provides a regulatory pathway for medical devices intended for diseases or conditions that affect small populations.

Food and Drug Administration Modernization Act (FDAMA) added the De Novo classification pathway under Section 513(f)(2) of the FD&C act, establishing an alternate pathway to classify new devices into class I or II that had automatically been placed in class III after receiving a Not Substantially Equivalent (NSE) determination in response to a 510(k) submission. In this process, a sponsor who receives an NSE determination may, within 30 days of receiving notice of the NSE determination, request FDA to make a risk-based classification of the device under section 513(a)(1) of the act. In 2012, section 513(f)(2) of the FD&C act was amended by section 607 of the Food and Drug Administration Safety and Innovation Act (FDASIA), to provide a second option for De Novo Classification. In this second pathway, a sponsor who determines that there is no legally marketed device upon which to base a determination of Substantial Equivalence may request FDA to make a risk-based classification of the device under section 513(a)(1) of the act without first submitting a 510(k).

Food legislation in the European Union and elsewhere includes both hazard- and risk-based approaches for ensuring safety. In hazard-based approaches, …

"Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual [cosmetic] products or ingredients. The law also does not require cosmetic companies to share their safety information with FDA."

The agency has released controversial new rules for evaluating a chemical’s risk

What is repeated dose toxicity (definition, NOAEL, subacute, subchronic, chronic toxicity), study design and how it is used for hazard classification and risk assessment.

{Extremely large collection of wide variety of searchable Data sheets, maps, etc. on environmental, health and other topics} "EnviroAtlas provides geospatial data, easy-to-use tools, and other resources related to ecosystem services, their chemical and non-chemical stressors, and human health. "

*******{Paying earlier registrants and researchers for ingredient efficacy & safety data studies you cite for your product's application} This chapter provides information about data compensation requirements, procedures, and obligations when submitting an application for registration, amended registration, reregistration or registration review. "For assistance concerning the data compensation procedures, please contact the appropriate Branch for your pesticide product."