Blog Post Life Sciences Medical Devices Breaking Down the Changes to 510(k) Clearance On November 26, 2018, FDA Commissioner Scott Gottlieb and Jeff Shuren, Director of the Center for Devices and Radiological Health, ...
Blog Post Consumer Products Quality & Regulatory Regulatory Implications of AI Toys The growth of Internet of Things (IoT) isn’t limited to self-driving cars and home security systems. AI toys can already ...
Blog Post Life Sciences Biotech Transparency in Clinical Study Reporting For pharmaceutical and biotechnology companies focusing on research and development, prioritizing data transparency and clinical study reporting (CSR) is a ...
Blog Post Life Sciences Medical Devices FDA Clearance of Apple Watch 4 Shows Key Trend in Medical Device Last week, Apple unveiled that it had received FDA clearance for the Apple Watch Series 4, further solidifying one of the top ...
Blog Post Consumer Products Food & Beverage ISO 22000 and the Importance of Food Safety In response to changes to diversity, globalization, and digitization across the industry, the International Organization for Standardization (ISO) recently announced ...
Blog Post Consumer Products Health & Beauty Quality in Cosmetics: Today and the Future Quality within the consumer products industry has long been a strategic imperative for manufacturers of the world’s best brands. The ...
Blog Post Consumer Products Health & Beauty Combating Counterfeit Cosmetics While consumers are on a quest to find deals for their everyday purchases, both consumers and manufacturers are combating the ...
Blog Post Life Sciences Biotech New 21 CFR Part 11 Guidance Emphasizes Data Integrity 21 CFR Part 11 (Title 21–Food And Drugs Chapter I–Food And Drug Administration Department Of Health And Human Services Subchapter ...
Blog Post Consumer Products Food & Beverage The Changing Landscape of the Pet Food Market In the United States, people are obsessed with their pets and this obsession is impacting the pet food market. It ...
Blog Post Life Sciences Generics GDUFA II Fees – What You Need to Know The Generic Drug User Fee Amendment (GDUFA II) will go into effect on October 1, 2017. It will create a ...
Blog Post Consumer Products Consumer Healthcare Cosmetics Companies Facing New Regulatory Oversight The United States Senate and House of Representatives are both working on new regulations that would significantly impact the cosmetics ...
Blog Post Life Sciences Generics 3 Operations Themes from the 2017 GPhA Annual Meeting Last week, we were fortunate to attend this year’s GPhA Annual Meeting in Orlando, FL. As always, the event offered ...
