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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.

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Can holograms help in the frontline fight against pharmaceutical counterfeiting?

European Pharmaceutical Review

Indeed, a 2020 operation coordinated by Europol across 27 countries led to the seizure of more than 25 million units of counterfeit anticancer drugs and erectile dysfunction medicines among other fake drugs worth nearly €73 million. Elsewhere, holographic labels have been deployed effectively to arrest declining sales of pharmaceuticals.

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

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Change is Inevitable – Plan Ahead: An Assessment of FDA’s Draft Guidance on Predetermined Change Control Plans for Artificial Intelligence/Machine Learning-Enabled Device Software Functions

The FDA Law Blog

a) , and related guidance documents (e.g., In February 2020, FDA granted a de novo classification request (DEN190040) for software intended to assist medical professionals in the acquisition of cardiac ultrasound images and that included a PCCP for future software modifications. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a)

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Can you overdose on Benadryl?

The Checkup by Singlecare

However, since children’s dosing recommendations may vary between Benadryl products, it’s best to check the package label for dosing instructions to ensure appropriate and safe dosing,” says Dr. Johnson-Arbor. The “Benadryl Challenge” is a social media trend that began in 2020. Children ages 6-11 can take 12.5-25

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FDA Publishes Proposal to Redefine the Implied Nutrient Contain Claim “Healthy” Changing Focus to Foods Rather than Nutrients Adding Limits on Added Sugar Content

The FDA Law Blog

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. It is focused on the nutrients in the food product rather than on it overall nutritional “quality.”.

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Trial bias concern scuppers Y-mAbs brain cancer drug in FDA vote

pharmaphorum

The FDA refused to accept Y-mAbs’ first regulatory filing for the drug in 2020, but awarded the company’s second attempt a priority review earlier this year.

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