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April 22, 2020
Published by Med Search on April 22, 2020
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Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency

Docket Number: FDA-2020-D-1136 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance is being issued to […]
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April 22, 2020
Published by Med Search on April 22, 2020
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ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers

Docket Number: FDA-2014-D-0547 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides answers to questions […]
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April 22, 2020
Published by Med Search on April 22, 2020
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ANDAs: Impurities in Drug Substances

Docket Number: FDA-1998-D-0021 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides revised recommendations on […]
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April 22, 2020
Published by Med Search on April 22, 2020
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ANDAs: Impurities in Drug Products

Docket Number: FDA-2010-D-0584 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance provides recommendations on what […]
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April 22, 2020
Published by Med Search on April 22, 2020
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Reporting Drug Sample Information Under Section 6004 of the Affordable Care Act

Docket Number: FDA-2014-D-0829 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research Office of Medical Products and Tobacco, […]
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April 22, 2020
Published by Med Search on April 22, 2020
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‘Eye-Opening’: Cognitive Decline With Endocrine Tx for Breast Ca ‘Eye-Opening’: Cognitive Decline With Endocrine Tx for Breast Ca

Cognitive impairment seen in women with early breast cancer who undergo chemotherapy ― so-called chemobrain ― has now been reported in patients who are treated with […]
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April 22, 2020
Published by Med Search on April 22, 2020
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How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD

Docket Number: FDA-2014-D-1891 Issued by: Guidance Issuing Office Office of Medical Products and Tobacco, Center for Drug Evaluation and Research This guidance describes how a prospective […]
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April 22, 2020
Published by Med Search on April 22, 2020
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Endocrine Disruptors in Pregnancy Tied to Obesity in Granddaughters Endocrine Disruptors in Pregnancy Tied to Obesity in Granddaughters

FROM ENDO 2020 Exposure during pregnancy to a specific per- and polyfluoroalkyl substance (PFAS), combined with a low cholesterol level, is linked to a heightened risk […]
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April 22, 2020
Published by Med Search on April 22, 2020
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Atkins, Ornish, DASH Diets Tied to Weight Loss, Lower Blood Pressure Atkins, Ornish, DASH Diets Tied to Weight Loss, Lower Blood Pressure

(Reuters Health) – Several popular diets that emphasize low-fat, low-carbohydrate, and moderate macronutrient eating patterns are associated with modest weight reduction and reductions in both systolic […]
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