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Pharmaceutical industry: 2023 in retrospect

Pharmaceutical industry: 2023 in retrospect
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Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities

Guidance provides applicants and manufacturers of drugs, including prescription and over-the-counter (OTC) drug products, with a recommended framework for predicting the mutagenic and carcinogenic potential of NDSRIs that could be present in drug products and recommends acceptable intake (AI) limits ....

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FDA Roundup: August 4, 2023

FDA Roundup: August 4, 2023
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FDA Roundup: August 4, 2023

/PRNewswire/ Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a new. ....

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FDA Roundup: August 4, 2023

FDA Roundup: August 4, 2023
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