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OTC Hearing Aid Proposed Rule Issued

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FDA issues for comment a proposed rule and draft guidance on OTC hearing aids and personal sound amplification devices.

Animal Drug Regs Amended on Application Actions

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Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions during January, February, a...

Adamis Gains Zimhi OK for Opioid Overdose

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FDA approves an Adamis Pharmaceuticals NDA for Zimhi (naloxone HCl injection, 5 mg/0.5 mL) for treating opioid overdose.

Melinta Raises Covid-Related Issue with Nexus ANDA

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Melinta Therapeutics says it did not receive a Nexus Pharmaceuticals Paragraph 4 certification for a generic form of Melintas Mino...

Sprint Nerve Stimulator Gains Broader Indication

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FDA clears an SPR Therapeutics 510(k) for a broader indication for use for its Sprint Peripheral Nerve Stimulation System head, n...

Oyster Point Nasal Spray for Dry Eye OKd

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FDA approves an Oyster Point Pharma NDA for Tyrvaya (varenicline solution) nasal spray 0.03 mg for treating signs and symptoms of ...

FDA Warns 2 Physician Researchers

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FDA warns two Hennepin County Medical Center researchers they failed to submit INDs for their clinical investigations.

Sen. Blumenthal Likely to Oppose Califf Nomination

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Sen. Richard Blumenthal (D-CT) tells a Bloomberg News reporter that he will likely oppose Duke University School of Medicine profe...

CGMP Deviations at Marcus Research Laboratory

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FDA warns Marcus Research Laboratory about CGMP deviations in its production of active pharmaceutical ingredients.

CGMP Violations at Sircle Laboratories

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FDA warns Sircle Laboratories about CGMP violations in its production of finished drugs.