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 Guidance Detailing Specific Requirements for Quality Agreements for Commercial Drug Manufacturing

On May 28, 2013, the U.S. Food and Drug Administration (FDA) published a draft guidance ("the Guidance") detailing the FDA's current thinking on contract manufacturing arrangements for drugs. Specifically, the Guidance...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

FDA Releases Two More Rules Implementing the Food Safety and Modernization Act

As we previously reported, President Obama signed the Food Safety and Modernization Act (“FSMA“) in January 2011 to help ensure the safety and security of foods in the United States. On January 7, 2013, the U.S. Food and...more

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