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Guidance on Sunscreen Active Ingredients

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Sunscreen Innovation Act: Withdrawal of a 586A Request or Pending Request.

Guidance on Sunscreen Advisory Committee Process

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Federal Register Notice: FDA releases a draft guidance: Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process.

FDA Extends Clozapine REMS Certification Deadlines

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Due to ongoing implementation challenges with a new Clozapine Risk Evaluation and Mitigation Strategies program, FDA extends its 1...

Califf Writes on Importance of Patient Perspectives

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A JAMA Viewpoint article authored by FDA commissioner-nominee Robert Califf describes ongoing efforts at the agency on patient pre...

Janssen Files NDA for Invokana/Metformin Combination

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Janssen Research and Development files an NDA for Invokamet XR, a once-daily therapy combining fixed doses of its Invokana canagli...

Event Medical Class 1 Recall of Inspiration Ventilators

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Event Medical begins a Class 1 recall of its Inspiration Ventilator System, i Series and LS 12.1 LCD models because a component on...

FDA Approves Takedas Ninlaro for Multiple Myeloma

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FDA approves a Takeda Pharmaceuticals NDA for Ninlaro (ixazomib) for combination use with two other therapies to treat people with...

FDA Posts 4 Guidances on Suncreen Testing

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FDA releases four draft guidances as required by the Sunscreen Innovation Act that provides the agencys current thinking on the sc...

More Concerns on Califfs Role in Xarelto Trial: POGO

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Duke Clinical Research Institute reexamines a study overseen by FDA commissioner-nominee Robert Califf amid concerns of potentiall...

Liptruzet Not Withdrawn for S&E

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Federal Register Notice: FDA determines that Liptruzet tablets 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg were not wit...