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Petition Seeks ECT Device Ban

[ Price : $8.95]

FDA gadfly attorney Jonathan Emord files a citizen petition asking that electroconvulsive therapy devices be banned or kept in Cla...

Guidance on Refuse to Receive ANDAs for Lack of Impurity Info

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Abbreviated New Drug Application Submissions Refuse to Receive for Lack of Just...

Guidance on Food for Animals CGMPs

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Current Good Manufacturing Practice Requirements for Food for Animals.

Guidance on Human Food By-products Used for Animal Food

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance for industry entitled Human Food By-Products For Use As Animal Food.

Lawmakers Ask FDA to Weigh in on EpiPen Alternatives

[ Price : $8.95]

Lawmakers write to FDA asking what it can do to ensure approval of competitive alternatives to Mylans EpiPen (epinephrine injectio...

FDA Guidance on Microbiology Data for Antibacterial Drugs

[ Price : $8.95]

FDA releases a guidance on Microbiology Data for Systemic Antibacterial Drugs Development, Analysis, and Presentation that is int...

Complete Response Letter for Amgens Parsabiv

[ Price : $8.95]

FDA issues a complete response letter for Amgens Parsabiv NDA.

Lilly to Appeal Adverse Axiron Court Decision

[ Price : $8.95]

Lilly says it will appeal an Indiana federal court ruling allowing generic forms of its Axiron testosterone drug.

FDA Cautions on Syringe Pump Flow Problems

[ Price : $8.95]

FDA cautions healthcare professionals that programmable syringe pumps can have flow continuity problems when used to infuse therap...

FDA Guide on ANDA Refusals Related to Impurity Limits

[ Price : $8.95]

FDA posts a guidance on ANDA Submissions Refuse to Receive for Lack of Justification of Impurity Limits that is intended to help...