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FDA Outlines Agenda for New Guidances in 2014

February 5, 2014

FDA plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.

FDA Prohibits Another Ranbaxy Facility from Producing Drugs for US Market

January 24, 2014

FDA adds Ranbaxy's Toansa, India facility to existing consent decree, prohibiting distribution of APIs from that location

Genzyme Receives Complete Response Letter from FDA on Lemtrada Application

December 31, 2013

Genzyme plans to appeal FDA?s decision that the multiple-sclerosis treatment is not ready for approval.

Baxter Initiates Worldwide Voluntary Recall

December 30, 2013

Baxter International recalls dextrose injection and four sodium chloride injections.

FDA Approves Extended-Release, Single-Entity Hydrocodone Product

October 28, 2013

Zhoydro ER is the first drug to have updated labeling now required for all ER/LA opioid analgesics.

FDA Takes Enforcement Action Against Dietary Supplement Manufacturer

October 22, 2013

FDA is seeking a permanent injunction against a dietary supplement manufacturer following the company?s repeated distribution of unapproved drugs and adulterated dietary supplements.

FDA Activities Continue During Government Shutdown

October 7, 2013

During the ongoing federal government shutdown, FDA activities will be limited to work involving the safety of human life or the protection of property, and activities funded by carryover user fee balances PDUFA, GDUFA, and MDUFA.

Judge Approves Consent Decree Against Shamrock Medical Solutions Group

September 18, 2013

Shamrock Medical Solutions Group, a drug repackaging and distribution company, repeatedly failed to comply with good manufacturing practices.

FDA Reissues Bioanalytical Method Validation Guidance

September 12, 2013

FDA updates guidance to reflect advances in technology.

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