Contaminated eye drops present serious risks. Not only can they cause blindness and other serious medical conditions, but they have also been linked to at least four cases of premature death caused by severe bacterial...more
The U.S. Food and Drug Administration (FDA) uses warning letters to notify manufacturers that they have violated the FDA’s regulations or federal law. Manufacturers that receive warning letters must respond promptly, and they...more
On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this update represents the first update to the...more
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
The U.S. Food and Drug Administration (“FDA”) regulates both finished dietary supplements (e.g., the “multi-vitamin” tablets that you might buy at the grocery store) and dietary ingredients (e.g., the B vitamins contained in...more
FDA recently published a Federal Register notice announcing a public listening session on good manufacturing practices (GMPs) for cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which...more
The recently enacted Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) requires FDA to adopt regulations governing Good Manufacturing Practices (“GMPs”) for the manufacture of cosmetic products and ingredients. H.R....more
A salmonella outbreak that sickened hundreds brought the largest criminal penalty ever imposed following a criminal conviction in a food safety case. Our Food & Beverage and White Collar, Government & Internal Investigations...more
The highly anticipated cosmetic regulatory overhaul, Modernization of Cosmetics Regulation Act (MoCRA), was signed into law on December 29, 2022, ushering heightened regulatory oversight of cosmetic products and facilities....more
Last month, the U.S. Food and Drug Administration (FDA) issued the final guidance “Homeopathic Drug Products,” which describes the agency’s approach toward prioritizing regulatory actions against homeopathic products that it...more
On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer Software Assurance for...more
The current regulation of cannabis products in the U.S. and Canada has left many dazed and confused. There seems to be a lot of confusion and misinformation on the regulation of these products on both sides of the border....more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
The U.S. Food and Drug Administration (FDA or Agency) recently announced the final guidance titled “Pre-Launch Activities Importation Requests (PLAIR)” (Final Guidance). ...more
Human health is a fundamental need of the society. The pharmaceutical industry has played a pivotal role in providing mankind with drugs for preventive and curative care. COVID-19 has further underscored the immense...more
On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more
The FDA has recently published a proposed regulation that will make its regulatory framework more closely aligned with the international framework used by other regulatory authorities around the world. If finalized, this...more
Manufacturing sites should prepare now for inspections before the U.S. Food and Drug Administration (FDA) resumes routine on-site inspections. Since 2020, FDA has delayed many routine inspections due to the pandemic. In...more
The Omicron variant has prompted considerable concern and uncertainty in the COVID-19 response, as public health leaders continue to advocate for vaccines and booster shots and researchers make progress in the development of...more
In March 2020, the Food and Drug Administration (FDA) issued temporary guidance documents allowing for the increased production of alcohol-based hand sanitizer during the COVID-19 outbreak. Due to that guidance, most...more
Under FDA's leadership, the International Council for Harmonisation (ICH) recently published Q13 draft guidelines on continuous manufacturing (CM) to advance the brand and generic drug industries ability to obtain approvals...more
The month of May was buzzing with good news for the edible insect industry, but this emerging food trend still faces regulatory uncertainty in the United States....more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more
On September 11, the U.S. Food and Drug Administration (FDA) issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,” urging drug manufacturers to...more