Angie Drakulich

Deviations happen. FDA recognizes this and requires deviations to be investigated and documented, say Peter Smith and David Elder. The former senior FDA officials are both in strategic compliance consulting at Parexel. When performing a deviation investigation, FDA expects certain things.

On Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) is cohosting a brand new national awards program at the Newseum in Washington, DC, to honor individuals and organizations who have contributed significantly to the advancement of patient care and medical innovation in the United States.

Change Management: How to Deal Published by Angie Drakulich on August 14, 2012 02:19 pm under Regulation Finding an effective and fully compliant change management system that works is not easy.

On Sept. 12, 2012, PhRMA is cohosting a brand new national awards program in Washington, DC, to honor individuals and organizations that have contributed significantly to the fight against Alzheimer's Disease.

Just about a year ago, in July 2011, FDA published a roadmap for addressing the challenges of globalization

Manufacturers willing to report bad news about the supply can help reverse the shortage trend.

Most of the products affected by growing drug and ingredient shortages are cancer medications, anesthetics used for patients undergoing surgery, emergency medications and intravenous electrolytes.

Enhancing bioavailability can be achieved through hot-melt extrusion (HME) or spray drying.

If your company has ever received a 483 from FDA, you likely had a ton of questions about how to respond, how to make things right, and fast.

This week, industry members and experts gathered in Philadelphia for two days of informal presentations and discussion regarding biopharmaceutical manufacturing partnerships.

Tomorrow opens the Biopharmaceutical Manufacturing Partnerships conference in Philadelphia, in coordination with CBI and Pharmaceutical Technology magazine.

It’s no secret that excipients are not manufactured specifically for pharmaceutical use. In fact, pharma appears pretty low on many excipient makers’ lists of clients.

It’s been a few months since the Obama administration launched the Big Data Research and Development Initiative, aimed at pooling large collections of data to gain knowledge and insight into everything from national security to the environment to biomedical research.

Taking time to appreciate the industry's greatest achievements will inspire growth ahead.

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

This guest blog was written by Christie Bloomquist is a partner in health practice at Hogan Lovells, a global legal practice firm based in Washington DC.

Here in Boston, the crowds are bustling at the BIO 2012 Convention and Exhibition. Today, BIO unveiled survey results that polled about 170 biotech industry leaders and 800 US voters, conducted by Hart Research and Public Opinion Strategies.

The revised US Pharmacopeia revised chapters on elemental impurity limits and procedures ( and ) are set to become official by the end of the year, and companies are beginning to think about implementation, which will be required by May 2014 (see back story).

Recognizing that traditional market forces – namely incentives related to intellectual property and a steady demand for products – have failed in developing countries, the World Health Organization (WHO) asked a member state-nominated group to come up with ways to fund R&D and pay for the treatment of neglected diseases in the world’s poorest nations. The group’s proposals will be discussed at the sixty-fifth session of the World Health Assembly, beginning today in Geneva.

The Pharmaceutical Research and Manufacturers of America and Biotechnology Industry Organization released statements last week regarding the Senate's vote to pass the Food and Drug Administration Safety and Innovation Act, which reauthorizes PDUFA.

ICH Q11, the anticipated guideline from the International Conference on Harmonization, titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonization process.

ICH Q11, the anticipated guideline from the International Conference on Harmonization (ICH) titled Development and Manufacture of Drug Substances, has achieved international consensus.

During the past two years, FDA has been looking more closely at enforcing Part 11 of the Title 21 Code of Federal Regulations regarding electronic records and signatures (see back story).

FDA issued a final rule on sterility testing on May 3, 2012, which amends the requirements for most licensed biological products and aims to provide manufacturers with the flexibility, as appropriate, to keep pace with technological and scientific advances. Many steps are changed or eliminated.

FDA’s Lucinda Buhse has been spearheading the agency’s spectral library of excipients as a means to improving supply chain security of the pharma industry, particularly focused on raw materials entering US borders (there are 300 entry points in total).

Industry experts working with extended-release injectables discuss challenges and solutions to formulating and manufacturing these complex products.

Apple's experience with manufacturing facilities in China present opportunity for future best practice.

Once again, Apple is doing something the rest of the world should be paying attention to, only this time it's about the company's approach to managing the global supply chain-even when things go wrong.

Jim Miller of PharmSource gave a keynote talk this week at Interphex 2012 in New York City on the state of the industry’s outsourcing environment.

PDA is hosting a few interesting workshops in the coming weeks on key topics facing the industry.