FDA Issues Final Rules That Change Nutrition Facts Labels
No more sugar coating—the Rules impose new label requirements, and manufacturers will incur additional costs. The US Food and Drug Administration (FDA or the Agency) has announced the issuance of two...
View ArticleCourt Strikes FDA Preapproval for Tobacco Product Labeling Changes
Court holds that FDA guidance cannot require preapproval for label modifications to existing tobacco products, but can require preapproval for quantity modifications....By: Kathleen Sanzo
View Article21st Century Cures Act’s Effect on Pharmaceutical and Biotechnology Industries
The 21st Century Cures Act contains significant new mandates for both the FDA and NIH that affect the pharmaceutical and biotechnology industries and are intended to advance drug research, discovery,...
View ArticleNew Approach for Biologic and Biosimilar Names
FDA final guidance will have significant impact on marketing of biologics, biosimilars and related products. This month, FDA issued its final guidance on Nonproprietary Naming of Biological Products...
View ArticleCongressional Committees Propose Restructuring of User Fees in Draft Language
The draft language reauthorizes FDA’s authority to assess user fees and proposes fee restructuring and increases. On April 14, the health committees for both the US Senate and the US House of...
View ArticleLawsuit Challenges GRAS Rule on Food Substance Safety
Public interest groups challenge FDA’s “Generally Recognized as Safe” Rule as failing to ensure food ingredients are safe for consumers....By: Kathleen Sanzo
View ArticleWhat Pharma Companies Need to Know about FDA’s New Draft IVD Guidance
As precision medicine gains momentum and in vitro diagnostics (IVDs) become increasingly used in clinical trials, pharma and biotech companies will need to develop expertise in evaluating IVD risk and,...
View ArticleFDA Issues Final Rule on Data Acceptance from Clinical Investigations for...
The US Food and Drug Administration’s new requirements for sponsors to follow Good Clinical Practices (GCPs) for ex-US device clinical trials will affect device development strategies, including where...
View ArticleFederal Right to Try Bill Becomes Law in Wake of State Laws
The federal bill was signed into law on May 30 by the president, and will present new opportunities and challenges to clinical trial sponsors and healthcare entities....By: Kathleen Sanzo
View ArticleFDA: Probiotic Products Can Use CFUs on Supplement Facts Panel
In a draft guidance document, the US Food and Drug Administration stated that in certain cases, it will allow probiotic products to use colony-forming units to quantify live microbial ingredients on...
View ArticleFDA Releases Policy on Risk-Based Inspections
The policy sheds light on risk factors but does not provide inspection predictability. Manufacturers should therefore continue to ensure inspection readiness....By: Kathleen Sanzo
View ArticleCalifornia to Ban Cosmetics Tested on Animals, Require Full Labeling for...
California Governor Jerry Brown is expected to sign into law two bills concerning cosmetic products sold in California. The first bill, SB 1249, would ban animal testing from all cosmetic products sold...
View ArticleLegalization of Hemp Production – An End-of-Year Present?
On December 20, President Donald Trump signed the Agriculture Improvement Act of 2018 (Farm Bill), which in part removes hemp and hemp-derived products, including cannabinoids, with less than 0.3%...
View ArticleSupreme Court Clarifies Judges Must Decide Impossibility Pre-Emption
The US Supreme Court held on May 20 that a judge, not a jury, must decide the question of whether federal law prohibited drug manufacturers from adding warnings to the drug label that would satisfy...
View ArticleFDA Clarifies Premarket Path for Ecigarette Products
The US Food and Drug Administration (FDA or the Agency) on June 11 issued the final guidance: “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems” (the ENDS Guidance),...
View ArticleLife Sciences International Review - Q2 2019
EU – REGULATORY - Brexit, Notified Bodies, and Medical Devices - The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light...
View ArticleFDA Extends Compliance Period for Wholesalers to Verify Returned Product
FDA on September 23 issued a Drug Supply Chain Security Act (DSCSA)– related compliance policy stating it will not take enforcement action against wholesalers that do not have systems in place to...
View ArticleLife Science International Review Q3 - Nov. 2019
Welcome to the Q3 2019 issue of our Life Sciences International Review. This issue covers new developments within Europe, Asia, and the United States in intellectual property, regulatory, pricing, and...
View ArticleThe Next Big Things: Insights for 2020
Autonomous cars, sports betting, and CBD products have burst onto the scene, setting the stage for major developments in how companies do business and how regulators monitor new innovations....By:...
View ArticlePotential Impact of Coronavirus (COVID-19) on the Pharmaceutical and Biotech...
The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands...
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