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WHO published a draft guidance on data integrity

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November 01, 2019

Read WHO draft data integrity guidance document

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Updated Ph. Eur. Chapter on plastic containers

October 29, 2019

A revised version of Ph. Eur. chapter 3.2.2. Plastic containers and closures for pharmaceutical use has been published in Pharmeuropa, Issue 31.4. The deadline for comments is 31 December 2019. In the revised version the list of commonly used polymers has been replaced with a cross-reference to "Materials used for the manufacture of containers" (Ph. Eur. 3.1 and subsections) to take into account additional materials that will be included in the future (e.g. 3.1.17 "Cyclo-olefin copolymers (COC)" and 3.1.18 "Styrene block copolymers for containers and closures for parenteral preparations and ophthalmic preparations", as previously announced in the Ph. Eur. Work Programme of March 2019). In addition, editorial changes have been made throughout the general chapter, including a change in the French title. Furthermore, in August 2019, a new Ph. Eur. Chapter with the title: 2.4.35 "Extractable elements in plastic materials for pharmaceutical use" has b...

US FDA conducts inspection at Alkem Labs Taloja facility

October 24, 2019

Alkem Laboratories Ltd has announced that the US Food and Drug Administration (FDA) had conducted an inspection at the company's bioequivalence center located at Taloja, Maharashtra from 14th October, 2019 to 18th October, 2019. At the end of the inspection, no Form 483 was issued, the company said.

Dr. Stephen Hahn Nominated to Head FDA

November 05, 2019

Radiation oncology expert Stephen Hahn, M.D., has been nominated as the new U.S. Food and Drug Administration commissioner. Hahn, 59, is chief medical executive of The University of Texas MD Anderson Cancer Center in Houston, and he has been a professor of radiation oncology there since January 2015, CNN reported. Ned Sharpless, M.D., acting commissioner of the FDA, will return to his role as the director of the U.S. National Cancer Institute, the U.S. Department of Health and Human Services said. The FDA has a $5.7 billion budget and more than 17,000 employees, CNN reported.