Manufacturing

Oct 01, 2008
Pharmaceutical Technology
The authors provide detailed lists of important checkpoints to consider when selecting an outsourcing provider.
Oct 01, 2008
Pharmaceutical Technology
The growth and globalization of the pharmaceutical supply chain make risk assessment more important than ever for pharmaceutical manufacturers. The authors describe a program to identify, prioritize, mitigate, and communicate risks in manufacturer–supplier relationships.
Sep 25, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
In an effort to clarify its policy on the use and creation of genetically engineered animals (GE animals), the US Food and Drug Administration released the draft guidance "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs" on September 18.
Sep 25, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
A new study concludes that an approval pathway for affordable follow-on biologics should be based on the Hatch–Waxman Act of 1984.
Sep 25, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
On November 3, the US Supreme Court will hear the case of Wyeth v. Levine, in which the drug company has challenged the ruling of a Vermont Supreme Court decision to award Diana Levine $6.8 million.
Sep 25, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
In a Sept. 17 letter to FDA Commissioner Andrew C. von Eschenbach, Rep. Henry Waxman (D-CA) questions the agency's priorities, specifically poking at FDA's political appointees and whether they are promoting industry at the expense of the public's health.
Sep 25, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Also, Zentiva accepts Sanofi's increased takeover bid, Oriel Therapeutics appoints Richard Fuller CEO, more...
Sep 18, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
MannKind and Pfizer (New York) agreed that the former company will help patients who need inhaled insulin switch from Pfizer's "Exubera" medicine to MannKind's "Technosphere Insulin" drug.
Sep 18, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
Earlier this month, the US Food and Drug Administration announced that it will be posting quarterly reports on its website regarding potential drug safety issues.
Sep 18, 2008
ePT--the Electronic Newsletter of Pharmaceutical Technology
By Pharmaceutical Technology Editors
Also, Quintiles to expand Singapore operations; Christine A. Poon, chairman of Johnson & Johnson's pharmaceuticals group, to retire; more...
native1_300x100
lorem ipsum