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Public Health › Abbreviated New Drug Application (ANDA) › Prescription Drugs

DLA Piper

CRLs Made Public: What FDA’s New Policy Means For the Drug Industry

DLA Piper on

The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under the agency’s initiatives to...more

Venable LLP

Life in the Fast Lane! FDA Announces the Commissioner's National Priority Voucher Program

Venable LLP on

On June 17, the Food and Drug Administration announced the establishment of the Commissioner's National Priority Voucher (CNPV) program. Although initial details are sparse, the CNPV promises fast action, allowing drug...more

Mintz - Health Care Viewpoints

OTC Monograph Reform: Key Takeaways and What Industry Can Expect

Mintz - Health Care Viewpoints on

On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which in part describes reforms to modernize the regulatory framework for over-the-counter (OTC) monograph...more

Wilson Sonsini Goodrich & Rosati

FDA Prioritizes Review Generic Drug Products to Treat Opioid Overdose

Wilson Sonsini Goodrich & Rosati on

Introduction: The Opioid Crisis - Every day in the United States, more than 130 people die after overdosing on opioids, such as prescription pain relievers, heroin, and fentanyl. These deaths are part of the ongoing,...more

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