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The rapid pace of AI implementation in life sciences requires action now to anticipate and manage risks. As best practices, applications, regulations, and risks evolve alongside AI technologies, life sciences [...]

1. General - Medicinal Products 1.1 What laws and codes of practice govern the advertising of medicinal products in your jurisdiction? Prescription Drugs In the U.S., prescription drug advertising is [...]

On February 9, 2023, the Senate Judiciary Committee (Committee) favorably reported to the full Senate five bills pertaining to biopharmaceuticals. The bills, which were also introduced in the previous legislative [...]

On December 29, 2022, President Biden signed into law the Consolidated Appropriations Act, 2023, a $1.7 trillion omnibus that will fund the federal government through the remainder of fiscal year [...]

Law and Practice 1. Applicable Product Safety Regulatory Regimes 1.1 Medical Devices The Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA) are the two [...]

1. General - Medicinal Products 1.1 What laws and codes of practice govern the advertising of medicinal products in your jurisdiction? Prescription Drugs In the U.S., prescription drug advertising is [...]

On June 28, 2022, the US Food and Drug Administration (FDA) published a much-anticipated proposed regulation (Proposed Rule)1 to establish parameters for nonprescription drug products with additional conditions for nonprescription [...]

1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices The primary legislation governing the authorisation, marketing, sale and supply of pharmaceutical products by the US [...]

The Public Readiness and Emergency Preparedness Act (PREP Act) provides immunity from liability to certain entities and individuals for claims of loss that have a causal relationship to the administration [...]

1. APPLICABLE PRODUCT SAFETY REGULATORY REGIMES 1.1 Medical Devices The Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA) are the two key statutes governing [...]

On September 10, 2021, the Acting Commissioner of the Food and Drug Administration (FDA), Janet Woodcock, published a letter to the US Patent and Trademark Office (USPTO) seeking increased exchange [...]

Introduction Whether a medical product is classified as a 'drug' or 'device' has significant regulatory implications, particularly for products that appear to meet the definitions for both 'drug' and 'device' [...]

Real-world evidence (RWE)-clinical evidence on the use and benefits or risks of a medical product derived from real-world data (RWD)-has become an important focus of industry and regulatory authorities alike, [...]

1 General - Medicinal Products 1.1 What laws and codes of practice govern the advertising of medicinal products in your jurisdiction? Prescription Drugs In the U.S., prescription drug advertising is [...]

Introduction Interest in real-world evidence (RWE) continues to increase among industry and regulatory authorities alike, with the belief that generating such data can be a cheaper alternative to costly randomised [...]

Just before the July 4 recess, legislators in the House and Senate put down two important markers for biomedical legislation expected to be in play for next year's Food and [...]

On June 8, 2021, the White House released its report, entitled 'Building Resilient Supply Chains, Revitalizing American Manufacturing, and Fostering Broad-Based Growth' (the Report), which consolidates four 100-day supply chain [...]

In March 2020, because of COVID-19 health risks and travel restrictions, the Food and Drug Administration (FDA) suspended most of its inspection program, both in the United States and abroad. [...]

1 . LIFE SCIENCES REGULATORY FRAMEWORK 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices The primary legislation governing the authorisation, marketing, sale and supply of pharmaceutical products by the [...]

Introduction In the first full day of his administration, President Biden issued 10 executive orders to serve as the cornerstone of what the Administration is calling the 'National Strategy for [...]

On December 4, 2018, the US Federal Trade Commission released a comment responding to the Food and Drug Administration's October 2, 2018 revised draft guidance titled Citizen Petitions and Petitions [...]

Virtually all pharmaceutical companies have been exploring the use of various software tools in both drug development and in conjunction with marketed products. In the future, such software will be [...]

In late September, the US Food and Drug Administration (FDA) released one draft and two final guidance documents regarding the implementation of the product identifier requirements under the Drug Supply [...]

On June 12, 2018, the US Food and Drug Administration (FDA) issued revised, final versions of two guidance documents, 'Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar [...]

On May 22, 2018, the United States House of Representatives passed 250-169 the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Mathew Bellina Right to Try Act of 2017 (S. 204), [...]

On December 7, 2017, the US Food and Drug Administration (FDA) announced several digital health policy documents designed to 'encourage innovation' and 'bring efficiency and modernization' to the agency's regulation [...]

As the focus on passing user fee legislation continues, the US Food and Drug Administration (FDA) has been moving ahead with implementation of the 21st Century Cures Act (Cures Act), [...]

Last week, the US Food and Drug Administration (FDA) issued a long-awaited draft guidance entitled 'Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities--Questions and Answers'1 (hereafter [...]

On July 29, 2016, the Food and Drug Administration's (FDA or the Agency) Center for Devices and Radiological Health (CDRH) finalized a guidance framing enforcement discretion policy regarding Low Risk [...]