Displaying 1–16 of 16 results for Hogan
Industry underdogs look giant challenges in the eye
Last week, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance addressing Data Integrity.
Novel technologies open a new avenue for developing the future of pharmaceutical manufacturing
FDASIA Title VII: Rx for Global Supply Chain Ills?
A detailed look at FDA's 2008-2009 Warning Letters, courtesy of Hogan & Hartson LLP.
Hiring people who already know their jobs and will faithfully do them over and over will not get us to a working model of QbD.
Compressing force is a dynamic number recorded as the attempt to maintain two target values in close tolerance
This update summarizes the pending Prescription Drug Marketing Act requirements, highlights pedigree requirements in Florida and California, and raises issues for consideration.
Rumors of 21 CFR Part 11s demise have been greatlly exaggerated. Data integrity is at the heart of numerous 483s and a recent lawsuit against Novartis.
This article, adapted from our "On Pharma" weblog, summarizes a number of the key pharmaceutical-related presentations from the BIO 2006 show, which was in Chicago from April 9 through 12.
Successful outsourcing in the pharmaceutical industry requires “governance,” and clear management of communications, performance, change and disputes.
Looming in the background, ready to pounce on any weakness in a drugs legal or patent status, are generics manufacturers. Generics are now a $40 billion annual industry and account for more than half of all prescriptions filled in the United States.