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Joanne S. Eglovitch

Senior Editor

Washington DC
Joanne Serpick Eglovitch is a senior editor for Pink Sheet where she writes about manufacturing quality issues. Joanne has over 20 years of experience covering the regulated pharmaceutical and medical device industries, and helped launch the “International Pharmaceutical Regulatory Monitor” and the “International Medical Device Regulatory Monitor”. Previously Joanne covered the mortgage finance industry and the mortgage capital markets, and employment and training programs. Before her forays into newsletter journalism, Joanne worked as a general assignment reporter for a twice-weekly newspaper in southern Maryland and an editorial assistant for “Insight” Magazine, published by “The Washington Times.”

Latest From Joanne S. Eglovitch

Outsourcing Facilities Need More Regulatory Transparency From FDA To Compound Drugs In Shortage

Greater clarity on which drugs outsourcing facilities can compound from bulk ingredients and what good manufacturing practice requirements they will have to meet would go a long way toward enabling them to help prevent and resolve drug shortages, Pew report says. Another factor to consider: whether any loosening of restrictions during the pandemic will continue afterward.

Manufacturing Quality

The EU's Top Valsartan Lesson: Closely Examine Active Substance Manufacturing Processes

EU report on “lessons learnt” from the valsartan crisis calls for tighter GMP controls on API suppliers.

Manufacturing Quality

The ICH Plans To Propose Q14 Guideline On Analytical Testing In January

The ICH is expected to release for public comment early next year its draft Q14 guideline establishing a lifecycle approach for analytical testing, as well as a Q2(R2) guideline to add some newer analytical methods.

Manufacturing Quality

Workforce Of The Future Initiative Aims To Close Skills Gap In Biopharmaceutical Industry

The biopharmaceutical industry is expanding its presence on college campuses to address a shortage of workers proficient in advanced manufacturing, cell and gene therapies and combination products. Executives say that not having enough of these skilled workers keeps them up at night.

Manufacturing Quality

Top US FDA Official Says New 'Playbook' Needed For CMC Reviews Of Gene Therapy Products

CBER director says lack of a clear regulatory structure is holding back the development and acceleration of gene therapy products, while industry says regulations should be flexible to keep up with changing technology for these products.

Manufacturing Quality

US FDA Sees Slow But Steady Progress In Adoption Of Continuous Manufacturing

The COVID-19 pandemic has prompted the ICH to delay by six months its efforts to develop Q13 guideline on continuous manufacturing, now not expected until May 2022.

Manufacturing Quality
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