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The FDA has revised its final guidance on investigating out-of-specification (OOS) drug test results, adding recommendations for evaluating results and revising outdated terminology. Read More
The FDA formalized user fee assessment changes under the Generic Drug User Fee Act of 2017 (GDUFA) in a final guidance released yesterday, adding a new section on refunds to sponsors. Read More
The FDA has removed a clinical hold it placed on Gilead Sciences’ experimental HIV-1 drug lenacapavir in December 2021 because of quality concerns about the drug’s borosilicate glass vials. Read More
The FDA gave the generic antidepressant fluvoxamine a decisive thumbs-down as a treatment option for COVID-19 this week, only days after an influential independent nonprofit research panel recommended it. Read More
Acella Pharmaceuticals is facing a potential class action lawsuit in a federal court in Georgia that claims its NP Thyroid hormone replacement drug is “worthless” and left one patient with “hypothyroidism, including hair loss, extreme fatigue, painful sensitivity to temperature changes and debilitating hives.” Read More
The FDA issued over-the-counter (OTC) drug and cosmetic manufacturer Allure Labs a four-observation Form 483 following a November to December 2021 inspection of its Hayward, Calif., facility, noting procedural lapses and possible underreporting of deviations, nonconformances and out-of-specification (OOS) events. Read More
A group of generic drugmakers pledged to manufacture versions of Pfizer’s COVID-19 antiviral pill Paxlovid (nirmatrelvir/ritonavir) for use in the developing world and agreed to price them at $25 or less per treatment course. Read More