Category: Resource Topic

EMA/CAT/80183/2014: Guideline on the Quality, Non-Clinical and Clinical Aspects of Gene Therapy Medicinal Products (GTMP)
The EMA guideline on quality, non-clinical and clinical aspects of gene therapy medicinal products (GTMP´s) builds on earlier documentation and [...]
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Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center…
Millions of Americans take medication daily to control their blood pressure. We recently found that some generic versions of one [...]
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FDA Announces Voluntary Recall of Montelukast Tablets by Camber Pharmaceuticals Due to Incorrect Drug in…
The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot [...]
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Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida…
Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal [...]
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Supplier Assessment Questionnaire Kit
Background on Supplier Assessment Questionnaire Pharmaceutical manufacturers and industry suppliers recognize the inefficiency and waste of resources when each individual [...]
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Standardization of Data and Documentation Practices for Product Tracing Guidance for Industry
On February 28, 2018, FDA issued draft guidance on Standardization of Data and Documentation Practices for Product Tracing. This draft guidance aims [...]
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Over Half Of U.S. States Have Now Seen Fatalities From Counterfeit Drugs Made With Fentanyl
During a roundtable discussion focused on the nation’s worsening opioid crisis, advocates for ensuring a safe drug supply shared new [...]
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