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FDA, EMA Chair Regulators Covid-19 Vaccine Meeting

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FDA co-chairs with the EMA a global regulators meeting on developing vaccines to address the Covid-19 pandemic.

Hangzhou Linkeweier CGMP Violations

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FDA warns Chinas Hangzhou Likeweier Daily Chemical Co. about CGMP violations in its production of finished drugs as a contract man...

CGMP Violations at Demarks DermaPharm

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FDA warns Denmarks DermaPharm about CGMP violations in its manufacturing of finished drugs.

Covid-19 Convalescent Plasma Emergency IND

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CBER solicits clinical trials to study using Covid-19 convalescent plasma as a treatment for the virus and says it is facilitating...

Suggestions for Substantial Evidence Guidance

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Two stakeholders suggest changes to an FDA draft guidance on demonstrating substantial evidence of drug and biological product eff...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Hangzhou Linkeweier Daily Chemicals and DermaPharm A/S.

Final Guide on Alcohol Makers for Hand Sanitizers

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FDA posts a final guidance entitled Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitize...

CDRH Lists Changes Due to Pandemic

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CDRH advises industry on steps the Center is taking to prioritize work during the Covid-19 public health emergency.

FDA, Pfizer EpiPen Caution

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FDA and Pfizer list four ways in which EpiPen and EpiPen Jr could have delayed injection or fail to properly inject.

FDA Import Relief for Personal Protective Equipment

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To increase U.S. coronavirus supplies, FDA is now providing instructions to manufacturers to speed personal protective equipment a...