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Shire Resubmitting NDA for Dry Eye Drug

[ Price : $8.95]

Shire says it plans to resubmit during the first quarter of 2016 its NDA for lifitegrast for treating signs and symptoms of dry ey...

Two FDA-483s List Theranos Issues

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FDA releases FDA-483s from inspections at two Theranos manufacturing facilities.

FDA Guidance on Nonclinical Data for Reformulated Drugs

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FDA posts a guidance on Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an...

FDA Clears Masimo Pulse Oximeter

[ Price : $8.95]

FDA clears a Masimo 510(k) for MightySat Rx, a fingertip pulse oximeter that uses the companys SET Measure-through Motion and Low ...

FDA Develops List of Bulk Drugs for Compounding

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Federal Register Notice: FDA develops a list of bulk drug substances that can be used to compound drugs in accordance with the 503...

FDA Develops List of 503B Bulk Drugs

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Federal Register Notice: FDA develops a list of bulk drug substances that can be used to compound drug products in accordance with...

Comments Sought on Electronic Device Registration

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Federal Register Notice: FDA seeks comments on information collection associated with electronic device registration and listing.

Guidance on Compounding Bulk Drugs by Outsourcing Facilities

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Federal Register Notice: FDA releases a draft guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503...

Guidance on Compounding Using Bulk Drugs Under 503A

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Federal Register Notice: FDA releases a draft guidance: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503...

FDA Exempts Gene Mutation Detectors from 510(k)

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Federal Register Notice: FDA intends to exempt autosomal recessive carrier screening gene mutation detection systems from premarke...