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FDA Watching Serological Tests for False Claims

[ Price : $8.95]

FDA says it is concerned that some firms are falsely claiming that their serological tests are FDA approved/authorized or that the...

Fast Track for Non-opioid Pain Drug

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FDA grants EicOsis a Fast Track designation for its lead drug candidate, EC5026, for treating neuropathic pain.

CARES Act OTC Monograph Provisions Explained

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Hyman, Phelps & McNamara outlines key provisions in the OTC monograph reform provisions included in the coronavirus recovery legis...

Lawmakers Press FDA on Covid-19 Test Accuracy

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Two House lawmakers ask FDA to provide information about Covid-19 test accuracy in the wake of testing failures earlier this year ...

Stimulation Device Final Rule Delay Sought

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The Judge Rotenberg Center asks FDA to delay indefinitely the effective dates for a final regulation banning the use of electrical...

Pfizer, BioNTech Developing Covid-19 Vaccine

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Pfizer and BioNTech say they are working together on clinical trials and manufacturing capacity for an mRNA Covid-19 vaccine.

Seneca Gets FDA Guidance on Phase 3 Trial

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Seneca Biopharma says FDA has provided significant guidance on the design of a Phase 3 trial for the companys neural stem therapy ...

Stakeholder Comments on Biologics Advertising Q&A

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Stakeholders comment on an FDA draft guidance on promotional labeling and advertising considerations for biological reference prod...

FDA Compounding Drug Updated Guidance

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FDA issues policy clarifications for drug compounders during the Covid-19 pandemic.

Manufacturing, Supply Chain Q&A

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FDA posts a question-and-answer document on drug manufacturing and site changes during the Covid-19 pandemic.