Investigational New Drug, IND Review, Basic for INDA, USFDA regulations, Non-clinical study overview, Updating INDA

A young girl lives in the Outer Hebrides in a small village in the years just before WWI. Isolated and hard by the shore, her life takes a dramatic change when a terrible tragedy befalls her.

Decorated British officer Jack Wallace must lead a band of Allied commandos across enemy lines to rescue Professor Hopper, an American scientist held hostage by the Nazis. With information that could turn the tide of war, these unlikely heroes must traverse enemy territory with an untrained US civilian, avoiding brutal Nazi mercenaries and non-stop bombing – with the fate of the war resting on their shoulders, the outcome of this mission will change the world forever; failure is not an option.

Work relationships can be hard. The stress of dealing with difficult people dampens our creativity and productivity, degrades our ability to think clearly and make sound decisions, and causes us to disengage. We might lie awake at night worrying, withdraw from work, or react in ways we later regret—rolling our eyes in a meeting, snapping at colleagues, or staying silent when we should speak up.

This Karate Kid sequel series picks up 30 years after the events of the 1984 All Valley Karate Tournament and finds Johnny Lawrence on the hunt for redemption by reopening the infamous Cobra Kai karate dojo. This reignites his old rivalry with the successful Daniel LaRusso, who has been working to maintain the balance in his life without mentor Mr. Miyagi.

EZdrummer 3 reinvents the role a piece of drum production software can play in a songwriting context. It gives you the creative reins to a comprehensive set of easy-to-use features that allow you to create full-fledged drum tracks without ever leaving the software.

Carmen Souza celebrates the life and music of emblematic pianist Horace Silver in her new album ‘The Silver Messengers’. After critically acclaimed versions of 'Song for my father' or 'Cape Verdean Blues', in her previous cd´s, she channels the common African heritage to shed a new light into Silver´s repertoire. Most compositions on the album are by the great American master but Carmen Souza totally reclaims them, in her inimitable style, full of energy, humour… and crazy creativity - the very symbol, or synonym, of jazz!