Susan Haigney

Industry experts provide insights on the challenges and importance of using buffers in downstream processing.

Industry experts discuss what the outsourcing market holds for 2016.

Industry experts discuss the development of process chromatography in bioprocessing.

Industry experts discuss challenges, trends, and innovations in fluid handling.

The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.

The use of single-use systems in downstream processing offers benefits in filtration and sampling and may reduce the risk of contamination.

Agency officials visit China to meet with Chinese regulators and industry representatives about keeping the pharma supply chain safe.

The directorate highlights achievements accomplished during the year of its 50th anniversary.

In late 2014, standards organizations continued to work towards harmonization and securing drug safety.

Ralph G. Neas, president and CEO of the Generic Pharmaceutical Association, requests that Congress get involved in the support of a more competitive drug market.

Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design

Industry experts discuss the implementation of QbD and PAT tools in biopharmaceutical manufacturing.

As a result of the passage of the Generic Drug User Fee Amendments Act, Janet Woodcock, director of the Center for Drug Evaluation and Research, announced her plan to reorganize the Office of Generic Drugs (OGD) into a super office that would include subordinate offices. The new super office would report directly to Director Woodcock, with Greg Geba continuing his role as OGD director.

The European Medicines Agency (EMA) will soon be phasing out follow-up measures to marketing authorisations in place of a new system of classification that will be introduced in a stepwise manner.

Congress Passes Generic Drug Act

FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen

FDA Updates List of Warning Letters

The European Medicines Agency's Committee for Orphan Medicinal Products made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP's recommendations were four designation applications for rare forms of lipodystrophy.

The National Institutes of Health have gained the participation of Abbott, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Pharmaceutical Research & Development, and Sanofi in their effort to advance new therapeutic research.

PDA Revises Technical Report on Sterilized Products

PDA Releases Technical Report on TBA and TCA Odors and Taints

The Center for Drug Evaluation and Research Ombudsman's office released its annual report detailing the common questions and complaints received by the office in 2011. A total of 461 inquiries was received, an increase of 11% from 2010. The majority of inquiries, 60%, originated from industry, with consumers accounting for 23%, healthcare providers 7%, FDA employees 5%, and other 5%.

FDA has issued Warning Letters to 10 companies that manufacture and distribute dietary supplements that contain dimethylamylamine, also known as DMAA. FDA cited the companies for marketing the supplements without submitting evidence that the products are safe.

FDA Reports Improvement in Drug Oversight.