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FDA Releases Draft Guidance on ANDA Submissions

June 12, 2014

Draft guidance from FDA includes information essential for the completion of ANDA applications.

EMA Changes Guideline on Drug Name Acceptability

June 4, 2014

EMA publishes revised guideline on the acceptability of names for drugs.

Wockhardt Cited by FDA for Quality Control Failures

June 4, 2014

FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.

Sartorius Stedim Biotech Launches New Generation of Single-Use Bags, Flexsafe

June 4, 2014

Innovative polyethylene film sets new benchmark

Roche Acquires Genia Technologies

June 4, 2014

Genia's DNA-sequencing platform will strengthen Roche's pipeline.

AMRI to Acquire Oso Biopharmaceuticals Manufacturing

June 3, 2014

AMRI adds commercial-scale sterile injectable manufacturing capabilities with acquisition of Oso Biopharmaceuticals.

FDA Creates Easy Access to FDA Public Data

June 3, 2014

FDA launches openFDA to provide easy access to FDA public data.

Repligen Acquires Bioprocessing Business of Refine Technology

June 3, 2014

Repligen acquired Refine Technology and its Alternating Tangential Flow system for continuous bioprocessing.

FDA Issues Guidance on Expedited Programs for Serious Conditions

May 30, 2014

FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.

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