This article discusses the phases from the product development to commercialization. Biologics are subject to 21 Code of Federal Regulations in order to meet the criteria established for safety, purity, and potency. Compliance to these regulations should be built based on a quality management system and risk management to capture changes during the product development and process validation phases and prepare a product and facility for inspection readiness. Post commercial...

The Association for the Advancement of Medical Instrumentation (AAMI) this week released a technical information report to help the medical device industry prepare for the revision of 21 CFR 820 (also known as the quality system regulation), which will harmonize with ISO 13485:2016 later this year. The most recent regulatory agenda says that sometime this month the US Food and Drug Administration (FDA) will issue a proposed rulemaking on the harmonization and moderniz...

Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development. The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition . These principles relate to the concept of ...

To ensure the National Drug Code directory is accurate, the US Food and Drug Administration (FDA) on Thursday sent a reminder to pharmaceutical companies that 31 December 2017 is the deadline by which the firms must update or certify their drug listings with FDA via electronic format. This applies to drug listings that were not initially listed or updated during the current calendar year and is the first deadline of the annual certification requirement under Part ...

As part of its implementation of the 21st Century Cures Act, the US Food and Drug Administration (FDA) on Wednesday released a list of more than 70 Class I medical devices that are now exempt from premarket notification requirements. “FDA’s action will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulation,” the agency said in a notice. The list includes a range of ...

Not all drugs approved by the US Food and Drug Administration (FDA) stand the test of time. In some cases, the drugs are eventually removed from the market, either because they are unsafe, ineffective or just because their sponsor no longer feels like making them. But how often do these withdrawals take place, and to what extent do they reflect concerns about the safety or efficacy of a drug? Background The question is the subject of a new analysis by Hyman, Phelps & Mc...

The attorneys general of New York and Indiana are urging the US Food and Drug Administration (FDA) to "overhaul" the way in which it regulates the manufacture of dietary supplements. Background In the US, dietary supplements are defined as an oral product containing a "dietary ingredient," including vitamins, minerals, herbs, botanical ingredients, amino acids or other dietary substance. Despite commonly being used to support consumer health, dietary supplements are re...

A new drug approved by the US Food and Drug Administration (FDA) to treat patients afflicted with the plague was reviewed under a rarely used regulatory pathway meant to sidestep ethical and practical testing concerns. Background In 2002, FDA passed the  Animal Efficacy Rule  ("Animal Rule"), a regulation which permits the approval of some products based on safety testing in humans and efficacy testing in animals. The rule, located at  21 CFR 314.600-650  (drugs) and  ...

A new draft guidance document issued by the US Food and Drug Administration (FDA) calls on sponsors of estrogenic, androgenic or thyroid activity drugs to interact with regulators early on in the review process to help assess the potential impact of their drugs on aquatic wildlife. Background FDA's requirements to conduct environmental testing are the result of the National Environmental Policy Act (NEPA) of 1969. The law required federal agencies to determine t...

Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. US medical device regulators at the Food and Drug Administration (FDA) have issued correcting amendments  to their post-market electronic Medical Device Reporting (eMDR) requirements to eliminate any disparities between those rules and their Unique Device Identification (UDI) system. All changes will affect federal regulation 21 CFR Part...

New guidance issued by the US Food and Drug Administration (FDA) could make it easier for companies to conduct clinical trials by explaining how federal regulators will permit companies to use electronic media like interactive websites to help facilitate the informed consent process. Background In the US, clinical trials are regulated by FDA and the Federal Food, Drug and Cosmetic Act (FD&C Act) . Under Chapter 21, Section 50.25 of the Code of Federal Regulations (...

Conducting clinical research is difficult. Patients need to be protected, protocols adhered to, results meticulously recorded and hundreds of regulations followed. And when all is said and done, the US Food and Drug Administration (FDA) estimates that complying with its clinical trial regulations takes almost 23 million hours each year. Background FDA regulates clinical trials under Chapter 21 of the Code of Federal Regulation , Section 312 (21 CFR 312). The section ...