CGMP

News & Analysis as of

Drug Compounding: Manufacturing Standards Announced for Outsourcing Facilities

In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than...more

Increased cGMP Enforcement has Gone International: South Korean Action Against Johnson & Johnson Serves as Warning

In Brief - In both the United States and abroad, food and drug regulatory and enforcement agencies are increasing current Good Manufacturing Practices enforcement, including criminal sanctions....more

White Collar Watch - June 2013

In This Issue: - Tools of the Trade: BP Case Shows Advantage of Pretrial Motions - Increased cGMP Enforcement has Gone International: South Korean Action Against Johnson & Johnson Serves as Warning - DoD...more

FDA Issues Final Rule Regarding CGMPs for Combination Products

On Tuesday, January 22, 2013, the United States Food and Drug Administration (FDA or “the Agency”) published a final rule regarding Current Good Manufacturing Practice Requirements for Combination Products. 78 Fed. Reg. 4307...more

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