SafetyCall health care professionals serve eleven different product markets. This diversity allows us an excellent opportunity for benchmarking of incidents across similar and dissimilar product lines. SafetyCall experts use their proprietary systems and processes to monitor adverse incident trends related to each product to determine if there is a product issue that puts a company or consumer at risk and advise clients on appropriate action to deal with virtually any product.
Companies that manufacture and or sell Agricultural Chemical products and pesticides have mandatory incident reporting requirements to the Environmental Protection Agency (EPA) in the USA and the Pesticide Management Regulatory Agency (PMRA) in Canada. If you have pesticides registered with the EPA or the PMRA, SafetyCall can assist you in meeting your regulatory obligations.
Animal Health and Veterinary Products
This broad industry can include Regulatory obligations mandated by both the EPA and the FDA, depending on the products, ingredients and intended uses. Whether your products are veterinary pharmaceuticals under FDA guidelines or for those products applied externally to the animal that have mandatory reporting obligations of the EPA, our staff of experts are here to help.
Consumer Goods cover a wide range of products including cleaning, household, personal care and food items. Many of these products may be subject to the rules of theToxic Substance Control Act (TSCA) Sections 8(c) and 8(e). Under TSCA, companies are required by the EPA to record, retain and in some cases report “allegations of significant adverse reactions.”
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]. While there is no mandatory requirement to report adverse events involving cosmetics, there is an expectation that manufacturers and responsible persons have systems in place to effectively monitor the safety of their products.
Are you compliant with the FDA regulatory guidelines as they relate to Dietary Supplements? All alleged adverse events involving dietary supplements must be documented and retained for a minimum of six years, regardless of severity. Any allegation of a serious adverse event must be submitted to the FDA within 15 days. Guidelines were enacted under the Dietary Supplement and Nonprescription Drug Consumer Protections Act which was passed into law in 2007.
Industrial Chemicals are used by other industries to make other products, plastics, paint, and explosives. From a regulatory standpoint, companies are required to know if their products fall under theToxic Substance Control Act (TSCA). For such products, companies are required by the EPA to record, retain and, in some cases, report “allegations of significant adverse reactions” to any substance/mixture they produce, import, process or distribute and that is not subject to mandatory surveillance compelled by other regulations.
Institutional products are primarily used in the janitorial or cleaning industry. Many of the products used in this industry are subject to the rules of theToxic Substance Control Act (TSCA) Sections 8(c) and 8(e). Under TSCA, the EPA requires companies to record, retain and, in some cases, report “allegations of significant adverse reactions” to any substance/mixture that they produce, import, process or distribute that is not subject to mandatory surveillance compelled by other regulations.
Medical Cannabis includes a variety of products containing one or more components from the Cannabis genus of plants. SafetyCall’s licensed health care practitioners provide adverse incident and adverse event management services to companies in the medical cannabis industry.
There are many different “classes” of medical devices that correspond with their complexity and regulatory mandates enforced by the FDA. Medical device reports (MDRs) describing serious adverse events must be submitted to the FDA within 5 days or 30 days depending on the nature of the report.
Drugs: Nonprescription (OTC)
Do you know your adverse event reporting obligations for nonprescription over the counter (OTC) drugs marketed in the USA and Canada? FDA and Health Canada have adverse event reporting guidance documents that provide direction with respect to compliance with the Canadian Food and Drug Act and the Dietary Supplement and Nonprescription Drug Consumer Protections Act, which recently passed into US law in 2006.
The safety of prescription drug products is monitored by regulatory agencies both pre- and post-market. US and Canadian pharmacovigilance practice guidelines describe not only the mandatory reporting requirements for serious adverse events reported domestically, globally and in the scientific literature global surveillance, but also the requirements for the preparation of periodic adverse drug experience reports containing a critical analysis of all adverse drug events occurring quarterly or annually, depending on the age of an approved drug.