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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

FDA 105
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Top 10 Journal Articles To Read During Your Infectious Diseases Pharmacy Rotation

IDStewardship

BCPS, BCIDP Article Posted 12 March 2023 As a pharmacist serving as a preceptor to students and residents in the area of infectious diseases since 2010, I have always been on the hunt for good infectious diseases journal articles for my learners to read. Authored by: Timothy P. Gauthier, Pharm.D.,

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Case Study 2 – The Journey Leading to an Approved NDA

Impact Pharmaceutical Services

In 2010, following a referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a mid-size biopharmaceutical company to assist them with an upcoming NDA for a new chemical entity in the treatment of an orphan condition. The Journey Leading to an Approved NDA. 5 clinical study reports.

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Case Study 2 – The Journey Leading to an Approved NDA

Impact Pharmaceutical Services

In 2010, following a referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a mid-size biopharmaceutical company to assist them with an upcoming NDA for a new chemical entity in the treatment of an orphan condition. The Journey Leading to an Approved NDA. 5 clinical study reports.

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6 vitamins for liver health

The Checkup by Singlecare

A 2010 study suggests that people with severe liver failure and cholestatic liver disease often have low levels of vitamin D. The upper limit of intake for vitamin A is 9000 IU daily, but it is important to know that toxicity has been documented with doses over 8000 IU daily.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. 2010 [cited 2024May]. 1 For use as prescription drugs, a botanical product must be approved by the FDA: to date, only two have gained this approval. Available from: [link] Wyard M.

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Are Flame Retardant Toxins Contributing to Your Thyroid Condition?

The Thyroid Pharmacist

Several years ago, after reading research about all of the toxins commonly used in flame retardants (and learning about all of the many products in my home that contain these chemicals… somewhat of a shocking list), I looked at my mattress label, only to learn it contained one of the chief offenders. Labels (Furniture, Fabrics, and Carpet).