22
Jun
FDA Updates

FDA Updates List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

The Agency has provided an updated list of drug products that are off-patent and have no unexpired period of market exclusivity and have no generic product approved.  The revised list contains a 2-part listing and an appendix. Part 1 contains 269 targets products for “those drug products for which FDA could immediately accept an ANDA […]

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17
Jun

FDA Appears to Be Signaling That They May Be Getting Closer to Regulating Homeopathic Drugs

Based on a news release titled, “FDA Warns Four Manufacturers of Unapproved Injectable Drugs Labeled as Homeopathic Drugs Pose Significant Risks to Patient Health and Violate Federal Law”, the Agency may be getting prepared to tackle regulation of the homeopathic drug market.  In the release, the FDA announces that it issued Warning Letters to four […]

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15
Jun

FDA Revokes Emergency Use Authorization for Chloroquine Phosphate and Hydroxychloroquine Sulfate

In an FDA new release (here), the Agency announced that it was pulling its EUA saying they “determined that the legal criteria for issuing an EUA are no longer met”.  The Agency took this action after a review of the current state of knowledge on the two drugs relative to their unproven efficacy and serious […]

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02
Jun

Additional Guidance on Hand Sanitizer – Preparation, Manufacture and Temporary Compounding: The Bar is Raised

FDA issued three updated guidance documents that have revised recommendations and additional information on the preparation, manufacture, and temporary compounding of hand sanitizers under the COVID-19 public health emergency.  The Agency provides additional guidance on the use of both active and inactive ingredients, updates permitted formulation and denaturing processes, and discusses permissible levels of impurities […]

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01
Jun

Consolidation of Publication for EUAs for Medical Devices Announced in the Federal Register

The Federal Register (FR), in a pre-publication notice today (here), outlined the general process for the authorization and issuance of emergency use authorizations (EUAs) similar to the ones they have been issuing during the COVID-19 pandemic.  The FDA is (as are other Agencies of the government) authorized to issue EUAs and are required to publish […]

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