FDA Law Blog
JANUARY 22, 2024
Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. Drug Supply Chain.
Pharmaceutical Technology
JUNE 5, 2023
Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. Right now, it’s compliance by checkbox, in a static way. Pharmaceutical companies that are publicly traded will need to pay attention,” warns Kim.
Pharmacy Checkers
DECEMBER 12, 2019
wholesale importation of lower-cost drugs. Opponents of Americans buying less expensive drugs from overseas pharmacies (i.e. Food and Drug Administration exemplifies the “gold standard” in drug safety. A majority of inspections resulted in findings of non-compliance. I agree with this 100%.
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