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The FDA handed Baoying County Fukang a warning letter after the company’s management withheld information from the agency and failed to maintain methods and controls in compliance with GMP standards. Read More
The FDA served drug manufacturer Japanese drugmaker Eisai a Form 483 after an inspection of its Baltimore, Maryland facility revealed recordkeeping and quality control issues that led to incomplete data and unrestricted access to computers. Read More
Amid concerns of rising pharmaceutical prices, HHS finalized a rule threatening fines against drugmakers that knowingly overcharge hospitals and providers under the 340B drug discount program. Read More
The FDA unlawfully delayed the admission of the drug thiopental sodium, a general anesthetic used to impose capital sentences through lethal injection, the Texas Department of Criminal Justice contends. Read More
In a loss for Sanofi and Regeneron, a federal judge upheld a jury verdict validating two of Amgen’s cholesterol drug patents for Repatha, denying a request to overturn the judgment and launch a new trial. Read More
Unrestricted access to electronic records and a series of quality control deficiencies resulted in a seven-observation 483 for a specialty drugmaker based in Maryland. Read More
FDAnews has compiled a list of the 21st Century Cures Act’s requirements and deadlines most relevant to the FDA and the pharmaceutical industry, including upcoming guidances, policies and public reports. Read More