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FDA 2 Weight Loss Device Guidances

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FDA publishes draft guidances to support clinical and non-clinical testing in premarket submissions for medical devices with a wei...

FTC Warns on Improper Orange Book Patent Listings

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The Federal Trade Commission issues a policy statement, which is supported by FDA, warning brand-name pharmaceutical companies tha...

FDA OKs Updated Temodar Indications

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FDA approves updated and revised labeling for Mercks Temodar under the Oncology Center of Excellence Project Renewal pilot program...

FDA Clarifies Safety of Phenylephrine Products

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FDA issues a safety clarification about its 9/12 Non-prescription Drug Advisory Committees decision that current scientific data d...

Zydus Petition on Indocin Suppositories

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Zydus Pharmaceuticals asks FDA to ensure that Indocin suppositories and their generics meet ICH guidelines and established impurit...

FDA, Rocket Agree on Phase 2 Danon Disease Trial

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Rocket Pharmaceuticals says it has reached an agreement with FDA on a pivotal Phase 2 trial of an investigational gene therapy for...

Safety Concerns Stop Eiger Phase 3 Hepatitis Trial

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Eiger Pharmaceuticals says it is shutting down the Phase 3 LIMT-2 trial of peginterferon lambda in patients with chronic hepatitis...

Supremes May Hear Label Preemption Case: Attorneys

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Two Knobbe Martens attorneys say the Supreme Court could clarify the bounds of federal preemption of state tort claims based on dr...

Include ICH Q12 in Gene Therapy Guidance: ISPE

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The International Society for Pharmaceutical Engineering says FDA should incorporate provisions in an ICH product lifecycle manage...

FDA Clears Wellysis Wearable ECG Patch

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FDA clears the Samsung Wellysis units wearable electrocardiography patch, S-Patch Ex.