Articles by Angie Drakulich - Pharmaceutical Technology

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Articles by Angie Drakulich

Global Healthcare on the Ground: Merck and AstraZeneca Tackle Cervical Cancer and Tuberculosis

Merck and AstraZeneca Tackle Cervical Cancer and Tuberculosis.
Nov 2, 2010

Merck and AstraZeneca Tackle Cervical Cancer and Tuberculosis.

Innovation In Depth

Connecting science and policy might increase support for innovation.
Nov 2, 2010

Connecting science and policy might increase support for innovation.

Biosimilars Hearing Begins Today

Nov 2, 2010

Today begins the two-day public hearing being held at FDA headquarters in Rockville, MD, to gain public in put on how to implement and regulate the follow-on biologics pathway that was cleared via President Obama's Biologics Price Competition and Innovation Act of 2009, which falls under the 2010 approved healthcare reform legislation.

FDA Issues Draft Guidance for Qualifying Drug-Development Tools

Oct 28, 2010

The US Food and Drug Administration issued a draft guidance last week on the Qualification Process for Drug Development Tools.

FDA Posts Minutes to PDUFA V Discussion Meeting

Oct 21, 2010

The US Food and Drug Administration has posted on its website the minutes of the PDUFA V reauthorizaton stakeholder meeting.

FDA Reports on Advancing Regulatory Science

Oct 14, 2010

The US Food and Drug Administration has released an implementation report on its Regulatory Science Initiative. The report outlines the agency's plans to advance regulatory science through new tools, standards, and approaches for assessing the safety, efficacy, quality and performance of FDA-regulated products, according to an agency press release.

USP Issues Explanatory Statement Regarding Recall of USP 33–NF 28

Oct 7, 2010

The US Pharmacopeia released a statement this week that explains in more detail last January's recall of the United States Pharmacopeia 33–National Formulary 28 (USP 33–NF 28).

Global Healthcare on the Ground: The PATH Malaria Vaccine Initiative

A look at MVI's malaria work in developing countries.
Oct 2, 2010

A look at MVI's malaria work in developing countries.

Amgen Recalls Products for Glass Flakes

Sep 30, 2010

Amgen (Thousand Oaks, CA) issued a voluntary recall last week of certain lots of Epogen(R) and Procrit(R) (Epoetin alfa) vials.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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