PIPELINE / Novack

found in the U.S. contains noactive ingredient (April 2012)

d The FDA is considering expandingthe definition of nonprescriptiondrugs in self-diagnosed and self-treated diseases (March 2012).

d The FDA received reports offungal endophthalmitis in patientswhowere given Brilliant BlueG, asprovided by a compounding phar-macy. Brilliant Blue G is not anapproved drug in the U.S. (March2012).

d The FDA has released a newguidance for medical devicemanufacturers seeking FDAapproval through premarket

198 THE OCULAR SU

approval or de novo decisionpathways. The guidance isscheduled to take effect withdecisions beginning May 1(March 2012).

d TheU.S. SupremeCourt in the caseof Mayo Collaborative Services vsPrometheus Laboratories said thatmerely telling doctors of a newscientific discovery and recom-mending theyuse it to treat patientsis not patentable (March 2012).

d The U.S. National Institutes ofHealth (NIH) started a collabora-tive program that will matchresearchers with a selection ofpharmaceutical industry com-

RFACE / JULY 2012, VOL. 10 NO. 3 / www.th

pounds to help scientists explorenew treatments for patients. Inthis program, NIH’s newNationalCenter for Advancing Transla-tional Sciences (NCATS) willwork with molecules initiallydeveloped for other indications(May 2012).

d U.S. legislators introduced billsthat would permit generic drugcompanies to update warninginformation about the drugsthey manufacture, a change thatcould allow patients to sue thecompanies for failing to warnabout the risks of taking theirdrugs (April 2012).

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