FDA completes Wyeth GMP inspection
FDA concludes its re-inspection of the Guayama, Puerto Rico manufacturing facility, Wyeth says April 5. The site passed a GMP inspection by EMEA at the end of March; the firm hopes to address FDA's observations in writing. Wyeth predicts the approval of compounds that are awaiting conclusion of the regulatory action will not be delayed (1"The Pink Sheet" March 5, 2007, p. 17)...
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FDA's inspection of Wyeth's Guayama, Puerto Rico manufacturing facility is taking longer than anticipated, but the firm does not expect the delay to hold up the launches of compounds it has pending at FDA, Chief Financial Officer Kenneth Martin said during a Feb. 28 conference call
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.
Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.