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Reassessing Drug Inspection Targets: FDA Updates Internal Policy for Risk-Based Site Selection Model

In a continuing effort to improve the quality system effectiveness of human drug manufacturing sites, FDA revised MAPP 5014.1, Understanding CDER’s Risk-Based Site Selection Model (Site Selection MAPP or the Policy)....more

One License to Unite Them All: FDA Proposes National Standards for Wholesale Distributors and Third-Party Logistic Providers

The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers” (Proposed Rule)—pursuant to FDA’s obligations...more

After a Series of False Starts, FDA Resumes Domestic Inspections

FDA announced on February 2 that it would be resuming domestic surveillance inspections across all product types, beginning on February 7, in light of declining COVID-19 rates. This announcement follows a series of inspection...more

Tracking Back to Track and Trace: Additional Guidance on Compliance with the DSCSA

Earlier in the summer, the FDA issued a quartet of guidance documents setting forth the Agency’s plan for implementing requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA directs FDA to build an...more

FDA Issues More Guidance on Gene and Cell Therapy Products

January was a busy month for the US Food and Drug Administration’s precision medicine efforts, as the agency produced guidance on ASO drugs for patients with debilitating or life-threatening genetic disorders and guidance on...more

FDA New Normal: Back to School with the A, B, CGMPs

The coronavirus (COVID-19) pandemic continues to impact the biopharmaceutical industry. In a recent guidance, Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency (the...more

CARES Act Provisions Impact Drug, Device, and Food Manufacturers and Suppliers

The $2 trillion economic stimulus package laid out in the Coronavirus Aid, Relief, and Economic Security (CARES) Act includes $11 billion in appropriations for vaccines, therapeutics, and other medical needs, and $34.9...more

FDA Issues New Temporary Policy for the Manufacture of Alcohol for Hand Sanitizer Products

In light of the hand sanitizer shortage during the coronavirus (COVID-19) pandemic, many manufacturers are seeking alternative sources of alcohol for incorporation into their hand sanitizer products. The need for alcohol has...more

Follow the Data: FDA Addresses cGMPs for Data Integrity Issues in Draft Guidance

The draft guidance provides insight into FDA’s expectations regarding data controls and compliance for pharmaceutical companies. In recent years, issues involving the integrity of and controls around manufacturing data...more

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