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FDA Releases Final Rule on PET Drugs

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An FDA final rule will require producers of PET drugs to submit NDAs or ANDAs for their drugs starting in two years.

Does Administration Favor Rx Drug Imports?

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The Obama administration sends mixed signals on whether it supports legislation to permit drug importation.

Repligen Mixed Results for MRI-enhancer

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Repligen reports mixed results from a Phase 3 clinical trial evaluating RG1068, a synthetic human secretin intended to improve mag...

Protalix Bio Submits NDA on Gauchers Therapy

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Protalix Biotherapeutics submits an NDA for taliglucerase alfa, a plant-cell expressed form of glucocerebrosidase (GCD) for treati...

Docket on Tobacco Retailer Training Established

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Federal Register Notice: FDA establishes a public docket to obtain suggestions on elements for an approved tobacco retailer traini...

FDA Issues PET Drug Guidance

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FDA issues a guidance with its thinking on how PET drug manufacturers can comply with cGMP regulations.

More FDA Effort Needed for Safety Responsibilities: GAO

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The Government Accountability Office says that FDA should develop a comprehensive plan and timeline for transferring more responsi...

Generic Biologics Still an Open Issue in Health Reform

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House and Senate health reform bill both support 12 years market exclusivity for branded biologics facing generic competition, but...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Aluwe, Burzynski Research Institute IRB, Chi Machine, Icon Clinical Research, PM...

Burzynski IRB Violations Cited

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FDA warns Burzynski Research Institute IRB about multiple violations of laws and regulations intended to protect human subjects.