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Regenerative Solutions Marketing Unapproved Drugs: FDA

[ Price : $8.95]

CBER says Regenerative Solutions of New Jersey is marketing unapproved exosome drug products for a variety of diseases and conditi...

FDA Blocking Fraudulent Covid Products

[ Price : $8.95]

FDA tells FDA Webview it has stepped up seizure of fraudulent Covid-19 products and substandard products coming through internatio...

Caris Life Sciences Submits 2 PMA Applications

[ Price : $8.95]

Caris Life Sciences submits PMA applications for two whole transcriptome sequencing precision medicine assays.

Multiple Issues at Professional Compounding Pharmacy

[ Price : $8.95]

FDA warns Professional Compounding Pharmacy about compounding regulation and CGMP violations in its production of compounded human...

Medical Device eCopy Submission Guidance

[ Price : $8.95]

FDA publishes a guidance explaining how the medical device eCopy Program will work as required by the FDA Safety and Innovation Ac...

FDA Glove, Gown, Mask Conservation Strategies

[ Price : $8.95]

FDA issues conservation strategies for a range of circumstances involving personal protective equipment used by healthcare provide...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Health Solutions Pharmacy.

Takeda Pharma Breakthrough Status for Mobocertinib

[ Price : $8.95]

FDA grants Takeda Pharmaceutical a breakthrough therapy designation for mobocertinib for treating patients with metastatic non-sma...

Bioequivalence Studies During Covid-19

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FDA discusses potential challenges to bioequivalence studies being conducted for submission with ANDAs during the Covid-19 pandemi...

Over 1,500 Companies Register to Produce Hand Sanitizer

[ Price : $8.95]

FDA says its flexibility during the pandemic has led to over 1,500 additional firms registering to produce hand sanitizer.