PhRMA Awards Celebrate Breakthroughs – And Get Warning On Prices
Merck's Keytruda highlights promise of FDA designation, but Tom Brokaw notes perils of industry's pricing strategy.
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FDA extends the PDUFA date for enzyme replacement therapy by three months so agency can review chemistry, manufacturing and controls information; another drug, Strensiq, is also pending at FDA without any action.
FDA Soft Sells GMP Quality Overhaul For Generics; Don’t Be ‘Anxious,’ Woodcock Says
‘In some ways our practices have played into the problems we’ve been having,’ CDER director tells GPhA annual meeting as she outlines her plan to ‘radically change’ manufacturing oversight.
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