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Ousted BARDA Director Bright Says Hydroxychloroquine EUA Distracted From Coronavirus Work

Rick Bright also tells House hearing that CDER Director Woodcock alerted him to the potential of the drug as a coronavirus treatment.

Coronavirus COVID-19 FDA

Injector Failure Guidance From US FDA Aims To ‘Balance’ Reliability And Feasibility

Injectors used for emergency administration of drugs such as epinephrine should be demonstrate a ‘remote probability’ of failure equating to no more than one in every 100,000 injection attempts, agency says in a new draft guidance that may have relevance for other types of emergency-use drug delivery devices.

Drug Delivery Guidance Documents

States Take Unusual Actions To Control On-Label Drug Supply Amidst COVID-19 Shortages

Sixteen US states have issued executive orders or other mandatory directives to preserve hydroxychloroquine and chloroquine for non-COVID-19 patients, while 26 states have issued similar voluntary guidance. The federal government is reserving some of the strategic national stockpile supply of the drugs for non-COVID-19, as private players in the supply chain also join in the efforts to balance on-label use with COVID-related demand. 

Coronavirus COVID-19 US States

Biosimilar Sponsors Push US FDA To Speed Up Supplement Reviews

Although the agency committed to six-month reviews of biosimilar and interchangeable supplemental applications, stakeholders say that time should, at minimum, be cut in half. Meanwhile, PhRMA's comments on a supplemental applications draft guidance urge the FDA to ensure interchangeability is demonstrated for all indications, even when some of those uses are ineligible for approval due to patent and exclusivity protection. 

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