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Guide on Contact Lens Performance Criteria

[ Price : $8.95]

FDA posts a draft guidance on Soft (Hydrophilic) Daily Wear Contact Lenses Performance Criteria for Safety and Performance Based ...

Clarifications Sought in Transdermal, Topical Draft Guidance

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Two companies ask FDA to clarify technical aspects of a draft guidance on the development of transdermal and topical delivery syst...

QS Violations Found in Silfradent Inspection

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FDA warns Italys Silfradent about QS and MDR violations in its manufacturing of the Surgybone medical device.

KemPharm NDA for ADHD Prodrug

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KemPharm files a 505(b)(2) for serdexmethylphenidate, indicated for treating attention deficit hyperactivity disorder.

FDA/CDC Make More Respirators Available

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FDA and the Centers for Disease Control and Prevention take action to make more respirators available to health care personnel bec...

FDA Sees SweynTooth Cybersecurity Vulnerabilities

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FDA warns about the SweynTooth family of cybersecurity vulnerabilities.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Acino Products, Chemland, Jiangsu JDC Medical Devices and Silfraden...

CPAPNEA Medical Supply Optipillows Violations

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FDA warns CPAPNEA about multiple violations in its manufacturing of Optipillows.

Name Covid-19-Related Drug Shortages: Public Citizen

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Public Citizen calls on FDA and drug industry trade associations to publicly identify all drugs that are in shortage due to the Co...

FDA Allows Broader Lab Testing as Virus Spreads

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As the coronavirus outbreak grows in the U.S., including two deaths over the weekend related to the illness, FDA implements a new ...