History of US Food & Drug Law
This fictional novel, written by Upton Sinclair and published in 1906, described unsanitary conditions in Chicago's meat packing plants and led to widespread public outrage and a demand for legislation.
What is "The Jungle"?
The present day US Food and Drug Administration (FDA) is part of the executive branch of government, and, specifically within this Department.
What is the Department of Health and Human Services (DHHS)?
This 1983 act originally defined a drug for a disease or condition which is rare in the US.
What is the Orphan Drug Act?
These filing types are typically known more specifically as supplements or variations depending upon the market.
What are post-approval submissions?
The US and New Zealand are the only two countries that allow this type of drug promotion.
What is Direct to Consumer Drug Advertising?
This act, which Congress passed in 1906, prohibited interstate commerce of mislabeled and adulterated drugs and food. The Bureau of Chemistry within the Dept. of Agriculture was assigned to enforce the provisions of the law.
What is the Pure Foods and Drugs Act?
The Agency serves the EU and three countries from the EEA—Iceland, Norway, and Liechtenstein.
What is the European Medicines Agency (EMA)?
This US market clearance process is employed to facilitate the approval of any drug that is not generally recognized as safe and effective.
What is a New Drug Application (NDA)?
Drugs that have special problems, particularly ones that may lead to death or serious injury, may have this warning message displayed within a box in the prescribing information.
What is a boxed warning or black box warning?
In this US, this mechanism is used to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic.
What is an Emergency Use Authorization (EUA)?
In 2004, concerns regarding food allergens led to passage of this act, which requires food labels to include specific statements regarding the presence of eight major allergens.
What is the Food Allergen Labelling And Consumer Protection Act?
This agency is within the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
What is the Medicines and Healthcare products Regulatory Agency (MHRA)?
Mindful of the fact that it may take an extended period of time to measure a drug’s intended clinical benefit, in 1992 FDA instituted these regulations. These regulations allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint.
What are Accelerated Approval regulations?
This refers to a drug's common name, which is the generally advertised name.
What is a brand name?
Compliance with these regulations are an important part of the drug development process and are a measure of the safety of the product prior to use in the indicated species.
What are Good Laboratory Practices (GLPs)?
This act, passed in 2003, gives FDA authority to require clinical research into pediatric use of new drugs and biological products.
What is the Pediatric Research Equity Act?
This Japanese specific agency is part of the Ministry of Health, Labor, and Welfare (MHLW) and they both handle a wide range of activities, from approval reviews to post-market surveillance for drugs and medical devices.
What is the Pharmaceutical and Medical Device Agency (PMDA)?
This US designation is described in the 21st Century Cures Act and pertains to certain biological products intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition; and preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for such disease or condition.
What is the Regenerative Medicine Advanced Therapy (RMAT) designation?
This type of BLA is how biosimilars in the US are filed. Hint: Think CFR.
What is a 351(k) application?
Manufacturers of licensed biological products in the US are required to report events, under this type of reporting on FDA form 3486, that represent unexpected or unforeseeable events or deviations from current GMPs, applicable regulations/ standards or established specs that may affect a product's safety, purity or potency and are no longer under the sponsor's control.
What is a Biological Product Deviation Report (BPDR)?
In the wake of the thalidomide tragedy in the 1960s, these amendments addressed the gap that required that food and drugs were required to show efficacy in addition to safety.
What are the Kefauver-Harris Amendments?
This decentralized agency and autonomous body run by a commissioner and appointed by the President of Mexico regulates health facilities, advertising activities and the manufacturing, import or export of health products.
What is the Federal Committee for Protection from Sanitary Risks (COFEPRIS)?
Non-clinical studies that are irrelevant or inadequate are two possible reasons that could lead to this type of delay in initiating a study under an IND.
What is a clinical hold?
This is a comprehensive, prospectively written plan for assessing the effect of a proposed CMC post-approval change(s) on the identity, strength, quality, purity, and potency of a drug product or a biological product, as these factors may relate to the safety or effectiveness of the product (i.e., product quality).
What is a comparability protocol?
This is the brand and former organization that predates G&L Scientific and was also founded by Stephen Loughrey.
What is Pharmalink Consulting?