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Karyopharm Fast Track for B-cell Lymphoma Drug

[ Price : $8.95]

FDA grants Karyopharm Therapeutics a fast track designation for selinexor, the companys first-in-class, oral Sine compound for tre...

Suggestions to Change Cancer Placebo Guidance

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Five major drug companies suggest changes to an FDA draft guidance on using placebo controls in cancer clinical trials.

7 Observations in MedisourceRx FDA-483

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FDA releases the FDA-483 with seven observations following an inspection at MedisourceRx.

Guide on Developing Fixed-Combination Hypertension Drugs

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Federal Register notice: FDA makes available a final guidance entitled Hypertension: Developing Fixed- Combination Drug Products f...

MRI Interventions ClearPoint Software Upgrade

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FDA clears an MRI Interventions 510(k) for its latest software platform, ClearPoint 2.0.

FDA Transitional Biologics Position Ripe for Litigation: Attorneys

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Attorney Scott Lassman says protein drug sponsors may sue FDA over a 2016 draft guidance on requiring BLAs for such products as of...

FDA Releases Akorn FDA-483 with 11 Observations

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FDA releases the latest FDA-483 detailing problems at another Akorn manufacturing facility, this time in Somerset, NJ.

Generic Drug Industrys Trade Agreement Concerns

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The Association for Accessible Medicines calls for changes to the proposed U.S.-Mexico-Canada Free Trade Agreement to better prote...

Facilitating Surrogate Endpoints in Drug Development

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FDAer Abena Agyemanm says the agency has published a table of surrogate endpoints that were used or could be used to indicate effi...