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DDMAC loses a letter but gains a new name and more prominence

USA - October 26 2011 It’s time to learn a new acronym....

Kelley Coleman Nduom.


Orphan drug exclusivity criteria clarified in court decision

USA - October 28 2014 A U.S. District Court has issued a decision that could affect the Food and Drug Administration's interpretation and determination in the orphan drug...

Alexander B. Foster.


FDA issues new draft guidance on combination therapy codevelopment

USA - January 24 2011 Combination therapythe use of two or more dugs to treat a disease or conditionhas become an increasingly important treatment option in fields such as oncology and infectious diseases....


An ounce of prevention: FDA issues guidance on contract manufacturing arrangements for drugs

USA - June 13 2013 In late May, FDA published a draft guidance entitled, Contract Manufacturing Arrangements for Drugs: Quality Agreements, to clarify the agency's...

Kelley Coleman Nduom.


Another One Bites the Dust: FDA doesn’t like the fishy smell of the latest court decision on off-label dissemination

USA - August 19 2015 The Food and Drug Administration has lost yet another court decision challenging its ability to restrict a company's commercial free speech rights...

William H. Kitchens.