<span class="archive__title-prefix>Posts Categorized:</span> Conference Spotlight

Author’s Note: The following is the conclusion of a four-part series covering a presentation by USDA Center for Veterinary Biologics (CVB) Senior Biologics SpecialistKendall Graberat theInternational GMP Conferenceheld virtually in March 2021. Part IV covers CVB’s role in product testing and release, and market release of serials, international harmonization efforts, and CVB’s work with international […]

[Author’s Note: USDA Center for Veterinary Biologics (CVB) Senior Biologics Specialist Kendall Graber discussed how the USDA manages compliance to the Title 9 regulations for animal biologics at the virtual International GMP Conference in March. Part I provided background on USDA’s authorities in this area while Part II provided a comparison of GMPs in 21 […]

*Updated April 26, 2023* China’s huge pharmaceutical market has long attracted the attention of international drug companies. But ferreting out how to gain access to the market and conduct clinical trials there has been elusive. China’s government recognized some time ago the benefits large pharma companies could bring to the country and its people and […]

[Author’s Note: Part I covered the history and background of the USDA’s Animal and Plant Health Inspection Services (APHIS)/Center for Veterinary Biologics (CVB), what the agency regulates and how, number of sites, products, and species regulated, and how it supports the health of the U.S. herd from a presentation by USDA CVB Senior Biologics Specialist […]

Intro to the Center for Veterinary Biologics (CVB) What U.S. government agency regulates and inspects biologics products for animals—for example, the rabies and distemper vaccines administered to dogs? FDA’s Center for Veterinary Medicine (CVM)? The answer is “No.” Veterinary biologics are regulated and inspected by the Center for Veterinary Biologics (CVB), an agency of the […]

Quality agreements between drug companies and the contract manufacturing organizations (CMOs) they employ have been the subject of controversy and FDA scrutiny for many years, prompting the drafting and release of FDA guidance on that topic in 2016. Warning letters and other regulatory actions have resulted from the lack of a quality agreement where one […]

Quality agreements between drug companies and the contract manufacturing organizations (CMOs) they employ have been the subject of controversy and FDA scrutiny for many years, prompting the drafting and release of FDA guidance on that topic in 2016. Warning letters and other regulatory actions have resulted from the lack of a quality agreement where one […]

Recent changes in Health Canada’s GMP inspection function include a reorganization and renaming from “the Inspectorate” to “the Regulatory Operations and Enforcement Branch” (ROEB) with inspectors dedicated and directed under a centralized program and performing only drug GMP inspections. New regulatory authorities include the ability to stop and enter a conveyance such as a semi-trailer, […]

At the International GMP Conference held virtually in early March 2021 co-sponsored by the University of Georgia at Athens and FDA, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit presented FDA drug GMP warning letter trends and provided in-depth case studies from recent drug Good Manufacturing Practice (GMP) inspections illustrating agency concerns […]

At the International GMP Conference held virtually in early March 2021 co-sponsored by the University of Georgia at Athens and FDA, FDA Office of Regulatory Affairs National Drug Expert Captain Ileana Barreto-Pettit presented FDA drug GMP Warning Letter trends and provided in-depth case studies from recent drug GMP inspections illustrating agency concerns and findings. Barreto-Pettit […]