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Groups Oppose McMurry-Heath as FDA Commissioner

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Some 26 healthcare organizations led by Public Citizen say they oppose the potential nomination of BIO CEO Michelle McMurry-Heath ...

FDA Alert on ENFit Low Dose Tip Syringes

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FDA issues a safety alert about the potential for overdose, under certain clinical use conditions, when using ENFit low dose tip s...

FAQ on Sodium Citrate Blood Specimen Collection Tubes

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FDA issues an online Frequently Asked Questions document on the shortage of sodium citrate blood specimen collection tubes used in...

Life Spine ProLift Expandable Spacer Cleared

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FDA clears a Life Spine 510(k) for the ProLift micro Expandable Spacer System for endoscopic transforaminal and posterior lumbar i...

Contract Testing Lab Hit with Warning Letter

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FDA issues a Warning Letter to contract testing laboratory Missouri Analytical Laboratories after a May inspection cited significa...

Panel to Review Pfizer Covid Vaccine in Kids

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Federal Register notice: FDA announces a 10/26 Vaccines and Related Biological Products Advisory Committee meeting to review and d...

FDA Changing Isotretinoin iPLEDGE REMS Requirements

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FDA approves changes to the isotretinoin iPLEDGE REMS.

Merck Seeks EUA for Oral Covid-19 Therapy

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Merck submits an application seeking emergency use authorization for molnupiravir, an investigational oral antiviral medicine that...

Quanterix Gets Breakthrough for Alzheimers Test

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FDA grants Quanterix a breakthrough device designation for its Simoa phospho-Tau 181 blood test as an aid in diagnosing Alzheimers...

Protagonist Therapeutics Hold Lifted on Trials

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FDA removes a Protagonist Therapeutics clinical hold on the company's rusfertide clinical tumor-detection studies.