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Akorn Pays $7.9 Million to Resolve False Claims Suit

[ Price : $8.95]

Akorn pays $7.9 million to resolve allegations that it caused Medicare to submit false claims by delaying an Rx to OTC switch for ...

Top FDA-483, Warning Letter Observations

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A MasterControl white paper lists the processes involved in the most common FDA medical device observations and Warning Letters.

FDA Grants, Denies Catalyst Amifampridine Petition

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FDA grants in part and declines in part a Catalyst Pharmaceuticals petition on using amifampridine to treat congenital myasthenic ...

Novartis Wants Restrictions on Entresto ANDAs

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Novartis asks FDA not to approve ANDAs seeking to produce a generic form of its Entresto under specific conditions.

FDA Rejects Hearing Aid Standardization

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FDA denies a petition asking it to standardize hearing aid features in new over-the-counter hearing aids and rate them.

FDA Partnership on Rare Neurodegenerative Diseases

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FDA joins the National Institutes of Health in launching a Critical Path for Rare Neurodegenerative Diseases public-private partne...

FDA Determines Review Period for Migraine Drug

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Eli Lillys migraine drug Re...

Bob Temple Gets New Title, Role Remains the Same

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CDER director Patrizia Cavazzoni removes Bob Temples deputy Center director title and renames him senior advisor for clinical scie...

MAPP on SGEs Representing Sponsors Before FDA

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CDER issues a Manual of Policies and Procedures for instances in which a CDER special government employee wants to represent a spo...

Regulatory Review Period for Bulkamid

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Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Conturas Bulkamid Urethral ...