Angie Drakulich

FDA talks about the changing scope of regulatory science and its effect on drug reviews, site inspections, and overall approaches.

From time to time, it's important to take stock of the industry from both a retrospective and prospective point of view.

FDA talks about the changing scope of regulatory science and its effect on drug reviews, site inspections, overall approaches.

PDA's strategic plan calls for maintaining valuable and effective relationships with global regulators.

An interview with Eric M. Parker, Ph.D., Executive Director and Neuroscience Site Lead, Merck Research Laboratories, about the Merck BACE team's winning research.

A look at the year's leaders in innovation strategy, including the top bio/pharmaceutical companies and award recipients from AAPS, PhRMA, and CPhI.

Want to know what the future of pharma science looks like? AAPS knows.

The editorial offices of PharmTech are based in New Jersey, so when Hurricane Sandy hit last month, we were all affected.

Laboratory best practices for meeting regulatory and compendial requirements are changing. FDA’s emerging expectations on data integrity.

Global tactics that incorporate online technologies and social media are reshaping disease response.

New England Compounding Center gets 483 after linked fungal meningitis outbreak.

The East Coast, including PharmTech’s offices, is largely boarding up and shutting down in preparation for Hurricane Sandy.

Dr. Lei Zhang of CDER’s Office of Translational Sciences gave an update at the AAPS Annual Meeting in Chicago yesterday regarding the agency’s regulatory science initiative.

At this week's AAPS 2012 Annual Meeting in Chicago, graduate students across the country are being honored for their research and work in bio/pharmaceutical innovation. Pharmaceutical Technology had the chance to talk with a few of the recipients.

At this week’s AAPS 2012 Annual Meeting in Chicago, graduate students across the country are being honored for their research and work in bio/pharmaceutical innovation.

The best approach to deal with an observation with which a company does not agree is to prevent an FDA-483 observation in the first place.

I’ll be in Chicago next week for the 2012 annual AAPS meeting and hope to see you there.

Will the next US President support the backbone of our industry?

What’s the best way to reach first-in-man studies when you have little to no information? Bioavailability issues, financial constraints.

Pharmaceutical Technology and Patheon are partnering to provide you-our readers-with CMC advice from some of the leading formulation scientists and pharmaceutical manufacturing experts in the world.

On July 9, 2012, the Generic Drug User Fee Act (GDUFA) was passed by the US Congress.

On July 9, 2012, the Generic Drug User Fee Act (GDUFA) was passed by the US Congress.

Earlier this week, on Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) honored nine individuals for their research into and fight against Alzheimer’s Disease (AD) as part of the association’s new Research and Hope Awards

In the September PharmTech issue, researchers from MIT’s Center for Biomedical Innovation (CBI) describe the interim results from recent research into 34 commercial-scale biopharmaceutical products at 11 international sites.

Delaying the onset of Alzheimer's disease by just five years could reduce the cost for care of Alzheimer's patients by $447 billion a year by 2050, according to a new PhRMA report.

Be sure to follow our Twitter feed from this year’s PDA-FDA Joint Regulatory Conference, taking place in Baltimore.

John Castellani, President of PhRMA, talks to PharmTech about its 2012 Research and Hope Award recipients.

On Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) will honor nine individuals for their research into and fight against.

IMS Health released its latest global spending report over the summer, confirming that times for the pharma market are indeed changing.

Cargo theft, for many years, was a problem that largely plagued the electronics industry, but criminals have recently shifted more attention to the far more lucrative pharmaceutical trade.