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FDA warns South Koreas Huons Co. about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
A Skadden Insights post raises the concern of FDA-regulated companies caused by the significant leadership changes at the agency.[ Price : $8.95]
FDA issues an early alert warning healthcare providers about a potentially high-risk device issue involving introducer kits used w...[ Price : $8.95]
FDA warns Amazon it is marketing unapproved new drugs on its Web site.[ Price : $8.95]
Former FDA commissioner Scott Gottlieb supports the agency's newly announced initiative to accelerate early-stage clinical trials...[ Price : $8.95]
FDA sends Achieve Life Sciences a Complete Response Letter on its NDA for cytisinicline as a treatment for nicotine dependence.[ Price : $8.95]
FDA releases the form FDA-483 with two observations from an inspection at the Pharmaneek non-sterile drug manufacturing facility i...