Displaying 1–17 of 17 results for Hogan

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Generic But Mighty

(Article)

Industry underdogs look giant challenges in the eye

Data Integrity the Focus of New FDA Guidance Document

(News)

Last week, the U.S. Food and Drug Administration (FDA) issued a Draft Guidance addressing Data Integrity.

Integrated Continuous Manufacturing

(Article)

Novel technologies open a new avenue for developing the future of pharmaceutical manufacturing

Taming the Supply Chain Monster

(Article)

FDASIA Title VII: Rx for Global Supply Chain Ills?

Current Trends in GMP Warning Letters

(Whitepaper)

A detailed look at FDA's 2008-2009 Warning Letters, courtesy of Hogan & Hartson LLP.

Therapeutic Dose: How Do You Test for Creativity?

(Article)

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: Myth vs Reality

(Article)

Compressing force is a dynamic number recorded as the attempt to maintain two target values in close tolerance

Pharmaceutical and Biotechnology Update : Drug Pedigrees

(Whitepaper)

This update summarizes the pending Prescription Drug Marketing Act requirements, highlights pedigree requirements in Florida and California, and raises issues for consideration.

From the Editor: Can Your Data Stand Up in Court?

(Article)

Rumors of 21 CFR Part 11’s demise have been greatlly exaggerated. Data integrity is at the heart of numerous 483s and a recent lawsuit against Novartis.

Report from BIO 2006

(Article)

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.

Governance: An Essential Component for Successful Outsourcing

(Article)

Successful outsourcing in the pharmaceutical industry requires “governance,” and clear management of communications, performance, change and disputes.

Beating Patent Death

(Article)

Looming in the background, ready to pounce on any weakness in a drug’s 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.

Drug Makers Fight Back!

(Article)

Less Is More

(Article)

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