A draft guidance in Q&A-format could help stave off missteps flagged in recent warning letters, more of which focus on data integrity. One basic piece of advice: data generated to satisfy a CGMP requirement is a CGMP record that must be retained.
Questions and answers about data integrity FDA published April 14 as draft guidance could go a long way toward helping drug manufacturers avoid the type of import alerts and warning letters that in recent years have dominated the agency's drug good manufacturing practices enforcement activities.
The percentage of firms placed on drug GMP import alert that have data integrity issues steadily has risen from zero...
The US FTC’s contention that ‘notice and choice’ has failed as the cornerstone of consumer privacy regulation and must be abandoned in favor of data minimization and other more stringent measures does not adequately account for the complexity of business practices and consumer behavior, FTC commissioner Melissa Holyoak asserted at the NAD’s 2024 Annual Conference.
FTC Commissioner Melissa Holyoak says the agency has acted outside the bounds afforded by Congress, citing several areas within consumer protection, including a recent update to the final rule for the Health Breach Notification Rule and the commission’s use of notices of penalty offense to serve as the basis for Section 5 settlements.
At one year, TikTok Shop conjures the early days of Amazon, representing the ‘Wild West’ of beauty ecommerce, said co-founders of private label and contract manufacturing company KO-Pack at the IBA Cosmetics Convergence Fall 2024 Virtual Symposium, “The Promise and Pitfalls of TikTok Shop.”
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AHPA CEO Rigby speaks at SoCal Consortium; CRN announces keynote speakers for St. Louis conference; FDA consumer health office chiefs on CHPA’s RS&Q agenda; NPA has VP For communications, regulatory affairs; COO appointed for Armorgenix; and Viatris consolidates digital, cultural, structural transfo
Class actions targeting cosmetics with PFAS are ‘far fewer’ now than in 2022 before state regulations were passed banning intentionally added PFAS in cosmetics, says an attorney who sees the state laws as a potential reason for the decline.
Reporting its first half sales figures, Germany's Dermapharm is happy with the progress made to turn around the performance of its dietary supplements subsidiary Arkopharma.
