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Smart Womens Choice Marketing Unapproved Contraceptive: FDA

[ Price : $8.95]

FDA warns Smart Womens Choice that its vaginal contraceptive cream is an unapproved new drug.

Abraxis Drug Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Abraxis Pharmaceuticals injectable manganese sulfate 0.1 mg/mL was not withdrawn due ...

Guide on Bispecific Antibody Development Programs

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Bispecific Antibody Development Programs.

Device Shortages Information Collection

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Federal Register notice: FDA sends to OMB an information collection revision on Shortages Data Collections.

FDA Reviews South Koreas Covid-19 Actions

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FDA reports on South Koreas actions to combat Covid-19, particularly involving diagnostic tests.

Guide on Pediatric Studies in Cancer Drugs

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Federal Register notice: FDA makes available a final guidance on molecularly targeted oncology drug pediatric studies.

FDA Mostly Positive on Teplizumab

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FDA says Provention Bios teplizumab was successful in a submitted BLA trial in delaying the onset of Type 1 diabetes in at-risk pa...

ChoiceSpine 510(k) for Cervical Spacer System

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FDA clears a ChoiceSpine 510(k) for the Blackhawk Ti Cervical Spacer System.

FDA Animal Antibiotic Concept Paper Substantially Flawed: Pew

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The Pew Charitable Trusts says an FDA concept paper on the duration of use of medically important antibiotic drugs used in or on a...

Keep Drug Companies Outside Clinical Trial Networks: Woodcock

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FDA acting commissioner Janet Woodcock calls for greater independence from drug companies in the nations clinical trial processes ...