FDA 510(k) is a submission process that medical device manufacturers need to go through to receive clearance from the US Food and Drug Administration (FDA) in order to legally market their products in the US. The FDA 510(k) process is essential for ensuring public safety by confirming that medical devices meet the necessary standards and […]
Visit with Lachman Consultants at Booth #600. The PDA Annual Meeting is a must-attend event for professionals in the pharmaceutical and biopharmaceutical industries. The three-day 2023 event is being held on Monday, April 3rd to Wednesday, April 5th at the Hyatt Regency New Orleans. As a leading forum for knowledge-sharing and networking, this year’s event […]
Lachman Consultants’ Vice President Ricki Chase joined Arnold & Porter to discuss the introduction of the Modernization of Cosmetics Regulation Act (MoCRA) including FDA’s authority to formalize good manufacturing practice (cGMP) requirements for the cosmetics industry. This is a landmark change to how cosmetics are filed, manufactured, traced, and reviewed by the Food and Drug […]
