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GPhA Wants More ANDA Pre-submission Communications

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Industry commenters call on FDA to provide NDA-type pre-submission communication opportunities to generic sponsors and include add...

ORA Expands MasterControl Quality Management Contract

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FDA contracts with MasterControl Inc. to expand its quality management software solutions and services in the agencys Office of Re...

FDA Approves Par NDA for Vasostrict

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FDA approves a Par Pharmaceutical NDA for Vasostrict (vasopressin injection) 20 units/mL, indicated for increasing blood pressure ...

Generic Drug Approval Backlog Hurts: Indian Companies

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Reuters reports that Indian drug industry executives say a continuing FDA backlog of generic drug approvals is hurting their U.S. ...

Brodalumab Tops Stelara Head-to-head: Study

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AstraZeneca and Amgen say their investigational psoriasis drug brodalumab topped Janssens Stelara in a head-to-head Phase 3 trial....

Some LDT Guidance Questions Answered But Many Not

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Attorneys Jamie Wolszon and Jeffrey Gibbs say FDAer Alberto Gutierrez answered some industry questions about the agencys draft gui...

FDA Funding UKs Bath University Research

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FDA funds research at the UKs University of Bath to help lower the cost of drugs.

FDA Orphan Status for Xeris Glucagon

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FDA grants Xeris Pharmaceuticals an orphan drug designation for its soluble glucagon, an investigational drug for preventing sever...

FDA Warns Firms Selling Unapproved Equine Meds

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FDA says it has issued Warning Letters to companies marketing unapproved animal drugs containing omeprazole.

Bill Introduced in Senate for Ebola Treatment Incentives

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Sen. Tom Harkin (D-IA) and Sen. Lamar Alexander (R-TN) introduce a bill to incentivize the development of treatments and vaccines ...