Topic

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

A realignment of the Office of Regulatory Affairs would create a focus on “critical activities” for ensuring the safety of foods and other regulated products, including drugs, biologics, and medical devices.

FDA Food Center Reorg Puts Field Inspections in Limbo 

Ashley Boam, MSBE, is the Director of the Office of Policy for Pharmaceutical Quality in FDA’s Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research. 

Theresa Mullin, PhD serves as CDER’s Associate Director for Strategic Initiatives and leads CDER’s International Program in FDA.

Harmonization of global regulations fosters innovation and ensures quality medicines.

Convergence in the Global Regulatory Village

Shifting guidance and the growing prominence of computer software assurance exemplify the state of computer software validation.

The Punctuated  Evolution of Computer Software Validation

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

The European bio/pharma industry’s high regulatory standards and GMP requirements are set to position the region as a frontrunner for pharmaceutical‑grade manufacturing of cannabis-based medicines.

Advantageous Positioning for Europe in Pharmaceutical Cannabis

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

A new unified initiative for patent protection in the EU to boost the competitiveness of the pharma industry is nearing completion.

Harmonizing Rules Governing SPCs for Medicinal Products

A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers. 

FDA Interactions with Industry Under Scrutiny

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Shiri Hechter is senior lab operations manager for Nelson Laboratories

Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating analytical methods.

Considerations for Method Validation

Mike Hennessy Jr. is the President and CEO of 

The restraint to not target solely the major disease groups has provided good proportion and balance for our industry.

Proportion,  Balance, and Restraint

FDA granted accelerated approval to Eli Lilly and Company’s pirtobrutinib for treatment of relapsed or refractory mantle cell lymphoma.

FDA Grants Accelerated Approval to Lilly Cancer Drug

FDA approved Stemline Therapeutics’ elacestrant for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.

Quality Systems