Malcolm has expertly covered the OTC drug and nutritional supplement industries and markets since 2006. He provides authoritative and highly analytical insight into how and why the US Food and Drug Administration regulates OTC drugs, including homeopathics, and nutritional supplement manufacturing and marketing and also how companies competing in these industries can most efficiently and effectively comply with FDA regulations, the cornerstone for their success.
Latest from Malcolm Spicer
FDA Center for Drug Evaluation and Research Office of Manufacturing Quality, Office of Compliance and Office of Unapproved Drugs & Labeling Compliance recently advise Indian, Canadian and US firms about GMP problems.
Challenged advertising, which appeared in a TV commercial, in-store displays and advertising on social media, included express claims “It’s a better mouthwash. I guarantee it.” and “I guarantee it. – ‘Dr. Harold Katz.’”
In remarks at recent investor conference reflecting comments from across the US consumer health sector, Kenvue chief Thibaut Mongon says, “I'm going to state the obvious. The environment is very fluid.”
Market growth and product innovations are continuing as FDA looks to Congress for authorization to establish regulatory pathway agency says it needs to determine whether to allow hemp-derived ingredients in food, dietary supplements and non-drug topicals including cosmetics.
Provisions in bill approved by Agriculture, Rural Development, FDA and Related Agencies Subcommittee aren’t likely to pass largely because they set a price too high for delta-8 THC and other ingredients to meet the definition of hemp as a de-scheduled substance.
Winterman moves from AstraZeneca to lead Perrigo supply operations; SunsolveMD fashions a brand ambassador in Elsa Hosk; Former P&G marketing exec Davis-Artis joins Godrej; and Epidiolex developer Wright advises BRC Th