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FDA Urges Caution with Hyperbaric Oxygen Claims

[ Price : $8.95]

FDA cautions consumers not to consider hyperbaric oxygen therapy for unapproved indications

Cybersecurity Guidance Raises Bar for Device Submissions: Attorneys

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Alston & Bird attorneys say that a FDA draft guidance on medical device cybersecurity raises many questions and concerns.

Incyte Plans Phase 3 Study in Pancreatic Cancer Patients

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Citing positive results from a Phase 2 study, Incyte says it is planning a Phase 3 trial involving ruxolitinib, its oral JAK1 and ...

FDA Warns Against Unapproved OTC Product

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FDA advises consumers not to use Ortiga, an unapproved product promoted for a variety of health conditions and sold on multiple We...

FDA Warns About Front Range Labs Testing

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FDA encourages pharmacies not to use Front Range Laboratories for quality testing services.

Comments Sought on Clinical Trial Participation Report

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Federal Register Notice: FDA establishes a docket to receive comments on an FDA report on clinical trial participation by demograp...

Guidance on Restricting Tobacco Sale to Children

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Federal Register Notice: FDA releases a guidance: Compliance With Regulations Restricting the Sale and Distribution of Cigarettes ...

FDA OKs Transdermal Delivery IND for Low Testosterone Studies

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FDA approves a Transdermal Delivery Solutions IND to evaluate Testagen TDS for treating low testosterone in men.

Takedas Vedolizumab Meets Primary Endpoints in Crohns Disease

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Takeda Pharmaceutical reports positive results from two Phase 3 studies evaluating vedolizumab in patients with ulcerative colitis...

IntelGenx Notified on Wockhardt Generic Forfivo ANDA

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IntelGenx says it has received a Paragraph 4 certification letter from Wockhardt Bio AG on an ANDA submission for a generic versio...