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Breaking Down the Cost of Generic Drug Production: Understanding the Factors Influencing Affordability

Drug Patent Watch

As we navigate the complex world of healthcare, it's easy to overlook the intricacies of generic drug production. We often assume that generic medications are cheaper because they're, well, generic. Generic drug production involves replicating a brand-name medication's active ingredient, formulation, and dosage.

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The Role of Scientific Expertise in Generic Drug Development

Drug Patent Watch

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

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Cybersecurity in pharma: Securing the future

Pharmaceutical Technology

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.

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CDER’s Office of Compliance Kicks Off Annual Report Season with Rundown of 2023’s Major Public Health Enforcement Initiatives

FDA Law Blog

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.

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Through the Looking Glass: Is FDA really the “Gold Standard” in Drug Safety?

Pharmacy Checkers

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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