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Perrigo Approval for First Generic ProAir HFA

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FDA approves a Perrigo Pharmaceutical ANDA for the first generic of Tevas ProAir HFA (albuterol sulfate) inhalation aerosol for tr...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Biomedix, JHS Svendgaard Hygiene Products, KVK-Tech, Unetixs Vascul...

Emagine Solutions VistaScan Cleared as Mobile Ultrasound

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FDA clears an Emagine Solutions Technology 510(k) for its cell phone VistaScan mobile ultrasound.

FDA Clears New LiveNova System Version

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FDA clears a new version of the LivaNova heater-cooler system 3T to help reduce the risk of patient infections.

Tytek Medical Recalls its PneumoDart-Pneumothorax Needle

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Tytek Medical recalls its PneumoDart-Pneumothorax Needle due to the risk of blocked needles caused by an adhesive left over from a...

Two Device Guides on CLIA Waivers

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FDA issues two final guidances to help device makers that seek Clinical Laboratory Improvement Amendments waivers for certain prod...

Lillys Trulicity Gains Cardiovascular Risk Reduction

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FDA approves Eli Lillys Trulicity (dulaglutide) for reducing major adverse cardiovascular events in adults with Type 2 diabetes wh...

150 Drugs on Virus-related Shortage Watch List: FDA

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FDA identifies about 150 prescription drugs (antibiotics, generics and some brand drugs) that could be in short supply if plants i...

Final Guide on Esubmission in eCTD Format

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Federal Register notice: FDA makes available a final guidance entitled Providing Regulatory Submissions in Electronic Format Cert...

Comments Sought on eCTD Tech Conformance Guide

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Federal Register notice: FDA seeks comments on a draft Electronic Common Technical Document v4.0 Technical Conformance Guide and t...