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regulations

5 Key Trends Impacting the Pharmaceutical Industry

The pharmaceutical industry is constantly evolving with new medications, changing regulations and pressure to reduce pricing. What’s next for the industry? Experts have identified five key trends emerging in 2019 that will significantly influence the way pharmaceuticals are manufactured and...

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FDA Noncompliance: Form 483 and Warning Letters in Environmental Monitoring

Companies operating in highly regulated industries are no strangers to FDA regulations, audits, inspections and noncompliance. Regulations cover a wide range of topics, from product labeling to environmental conditions to manufacturing practices. Companies operating in the medical device,...

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USP <795> and <797> Revisions: What Compounders Should Know

The United States Pharmacopeial Convention, or USP, is a nonprofit science-driven organization that establishes standards for medicines. These standards are developed with independent experts and are primarily published in a compendium of General Chapters. While USP deals with quality and...

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