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Repeat Medline CGMP Violations Cited

[ Price : $8.95]

FDA warns Medline, Inc., about CGMP violations in its manufacturing of drugs at its Waukegan, IL, facility.

CGMP Violations at Laboratorios Jaloma

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FDA warns Mexicos Laboratorios Jaloma about CGMP violations in its production of finished drugs.

Manufacturer Economic Info Communications Q&A Guidance

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FDA publishes a draft question-and-answer guidance on manufacturer communication of health care economic information to payors.

ICH Finalizes Guide on Model-Informed Drug Development

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FDA makes available an International Council for Harmonization guidance that establishes a global framework for using computationa...

Guide on Using Prior Knowledge for Genome Editing Gene Therapies

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FDA posts a draft guidance outlining how developers of genome-editing gene therapies can leverage existing scientific and manufact...

FDA Challenged to Keep Up With ALS Therapies

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Former FDAer Peter Pitts says the agency must become more consistent in its application of innovative review methods to keep pace ...

Drop Rabbit Pyrogen Test References: Petition

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Animal Defenders International petitions FDA to remove all references to rabbit pyrogen testing from its regulations and permit th...

FDA Orders Takeda to Add Boxed Warning to Adzynma

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FDA orders Takeda Pharmaceuticals to strengthen the safety labeling for its rare disease therapy Adzynma, including the addition o...

Cingulate Gets FDA Complete Response Letter on ADHD Drug

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FDA issues Cingulate a complete response letter on the company's NDA for CTx-1301, an investigational treatment for attention-defi...

Early Alert on Abiomed Introducer Kits Due to Serious Injuries

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FDA issues an early alert regarding a potentially high-risk problem involving certain Abiomed catheter introducer kits used with t...