COVID-19

20
Apr

All Hands-On Deck – Pharmacy Compounding for Hospitals of Certain Drugs Approved in a Pinch

Early on Monday morning April 20, 2020, the FDA announced a relaxed policy for pharmacy compounders, if there is a shortage of certain drug products to treat COVID-19 patients that are not available through the normal supply chain or from a registered outsourcing facility. The guidance, titled Temporary Policy for Compounding of Certain Drugs for […]

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13
Apr

FDA Takes Action to Finalize Two BE Guidances – For Guess What?

On the Federal Register prepublication page (here), the FDA gives notice of the finalization of two guidance documents providing bioequivalence recommendations for two drug products that have received a lot of recent news attention, chloroquine phosphate and hydroxychloroquine sulfate.  The two products have received attention because of the COVID-19 pandemic and the anecdotal reports of […]

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09
Apr

COVID-19 and Shortage-Related Requests for Manufacturing Process and Site Changes

On April 7, 2020, FDA released a Q&A on manufacturing and supply change requests related to COVID-19 and drug shortages.  In this Q&A, FDA provided the following guidance:   Manufacturing site changes because of supply chain disruptions related to COVID-19 – If the site change is for treatment of patients with COVID-19 or for drugs […]

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06
Apr
Woman with face protective mask

Let’s Face It! Protective Masks Have Revised Enforcement Policy Issued by CDRH

The Center for Devices and Radiological Health (CDRH) issued a revised guidance describing its policy on enforcement strategy for public personal use and filtered healthcare professional face masks titled Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (here).  The CDRH says the relaxed policy will remain in effect […]

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01
Apr

CTAP Program to Accelerate COVID-19 Drug Development and Approval

  Today, the FDA announced (here) its Coronavirus Treatment Acceleration Program (CTAP), which is designed to use “every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.”  The FDA will continue to enhance this emergency program to bring safe […]

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01
Apr

Lachman Reach-Out to New Hand Sanitizer Producers in Support of the COVID-19 Effort

Lachman Consultants is reaching out to U.S. distilleries and fermenters to provide support and guidance for the manufacture of hand sanitizers.  In response to several phone calls from industries wanting to help in the COVID-19 efforts, Lachman is responding with an interpretation of the most recent guidance from the U.S. Food and Drug Administration (here […]

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