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FDA Approvals - FDA Delays Hit Genzyme, Isis JV Deal (TheStreet.com) Regulatory demands


FDA Delays Hit Genzyme, Isis JV Deal (TheStreet.com)
Regulatory demands will result in delays for cholesterol-lowering candidate Mipomersen. Isis gets a downgrade on the news.

Akorn-Strides, LLC Announces FDA Approvals for Ondansetron Injection USP, 4 mg/2mL Single Dose Vials and Ondansetron ... (Business Wire via Yahoo! Finance)
BUFFALO GROVE, Ill.----Akorn-Strides, LLC today announced the approvals of two ANDAs for Ondansetron Injection USP, 4 mg/2mL Single Dose Vials and Ondansetron Injection USP, 40 mg/20mL Multiple Dose Vials.

FDA Cannot Properly Inspect Foreign Companies That Manufacture Medications, Medication Ingredients, Report Finds (Medical News Today)
FDA does not have adequate resources to inspect foreign companies that manufacture medications or medication ingredients, and current funding levels for the agency will not address the issue, according to a Government Accountability Office report presented on Tuesday at a hearing of the House Energy and Commerce Oversight and Investigations Subcommittee, the Newark Star-Ledger reports.
 

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