Most Viewed Articles - Pharmaceutical Technology

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ISPE Issues Guidance for Packaging, Labeling, and Warehousing Facilities

July 9, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

ISPE has issued a guidance that is intended to help companies meet cGMP requirements for packaging, labeling, and warehousing facilities and avoid problems such as product adulteration, product mix-up, label mix-up, and misbranding.

FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen

July 3, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA has issued a draft guidance on the labeling of OTC products that contain acetaminophen. The draft guidance would give manufacturers an alternative option to properly clarify the risk of liver damage in OTC acetaminophen-containing products.

GSK Agrees to $3 Billion Settlement with Justice Department

July 3, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

GlaxoSmithKline has agreed to plead guilty and pay $3 billion to resolve criminal and civil liability resulting from unlawful promotion of certain drugs, failure to report safety data, and alleged false price reporting practices.

Bristol-Myers Squibb Agrees to Acquire Amylin for $5.3 Billion

July 2, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

Bristol-Myers Squibb has agreed to acquire the biopharmaceutical company Amylin Pharmaceuticals for a purchase price of $5.3 billion and an additional $1.7 billion for assuming Amylin's net debt and a contractual payment obligation to Eli Lilly based on Amylin's recently terminated agreement with Eli Lilly over the diabetes drug exenatide.

Atypical Visible Particles

July 2, 2012

Pharmaceutical Technology

An industry roundtable on how users and makers can best assess and manage black specks.

High-Potency Manufacturing Remains Strong

July 2, 2012

Pharmaceutical Technology

Companies roll out expansions in manufacturing high-potency APIs and finished products.

Commentary: Healthcare Reform is Ruled Constitutional

June 29, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

In a 5–4 vote, the Supreme Court has ruled in favor of the Constitutionality of the Affordable Care Act.

EMA Finalizes Pharmacovigilance Guidelines

June 28, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency has published its first set of finalized guidelines concerning good pharmacovigilance practices.

EMA Investigates Roche for Deficiencies in Safety Reporting

June 28, 2012

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Medicines Agency has launched an investigation into Roche after an inspection found that thousands of potential safety reports, including 15161 deaths, connected to Roche medicines had not been evaluated to determine whether they should be reported to regulators as adverse drug reactions.

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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerTargeting Different Off-Shore Destinations
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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