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Dear FDA: WTF?

World of DTC Marketing

SUMMARY: The FDA wants to look at how certain brand names affect consumer and health care providers’ perceptions about the efficacy and the medical conditions for which they’re indicated. This is just another example of how clueless the FDA is regarding patient behavior and prescription drugs. The post Dear FDA: WTF?

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A Non-Profit Pharma Nabs FDA Nod for Non-Prescription Naloxone Nasal Spray

MedCity News

The FDA approved RiVive, an over-the-counter version of naloxone nasal spray from Harm Reduction Therapeutics. It’s the second such approval from the FDA this year, following an affirmative decision in March for OTC Narcan.

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Owlet Announces FDA-Clearance of the First Prescription Pulse Oximetry Sock for Infants

Legacy MEDSearch

Food and Drug Administration (“FDA”) of BabySat , the first medical pulse-oximetry device featuring its advanced, wire-free sock design. The addition of the FDA-cleared BabySat device expands on Owlet’s existing portfolio of consumer products designed to bring peace of mind to caregivers. BabySat will be available in the U.S.

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Regulatory Roundup: Narcan’s Nod, an ALS Adcomm, FDA Holds Lifted & More

MedCity News

Narcan, a nasal spray product that reverses the effects of opioid overdose, is now FDA approved for non-prescription use. Other recent FDA approvals include decisions for drugs from Pharming Group, Incyte, and Aurion Biotech.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. Ben Locwin will discuss the potential effects of this draft, along with the pharmacological and toxicological considerations for optimizing doses of prescription drugs. What will the future hold for clinical research?

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New FDA head needs to examine the accelerated approval program

World of DTC Marketing

The FDA’s “accelerated approval” program expedites the evaluation process for new treatments so that patients can have access to them sooner. Between 2011 and 2018, cumulative spending on 44 FDA-approved oral targeted therapy drugs was $3.5 appeared first on World of DTC Marketing.com.

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US FDA approves Bausch + Lomb and Novaliq’s DED treatment Miebo

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval to Bausch + Lomb and Novaliq’s Miebo (perfluorohexyloctane ophthalmic solution) to treat the signs and symptoms of dry eye disease (DED). It is the first and only prescription eye drop to receive FDA approval to treat DED that targets tear evaporation directly.