RA
505(b)(2) vs. ANDA | Choosing the Right FDA Pathway for Drug Approval
Chief Pharmacist
Navigating the U.S. regulatory landscape requires a clear understanding of approval pathways, especially when deciding between 505(b)(2) New Drug Applications ...
Regulatory CMC Comparison | US vs. EU Market
Chief Pharmacist
Understanding the regulatory requirements for Chemistry, Manufacturing, and Controls (CMC) is crucial for global product success. Here’s a quick comparison ...
Regulatory Authorities
Chief Pharmacist
Regulatory authorities enforce legal frameworks for new drug products or medical devices approval in market. For example, US FDA oversees ...