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FDA Releases Draft Guidance on Essential Drug Delivery Outputs

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

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Intranasal Therapeutics and Drug Delivery Systems: The Perfect Alternative to Conventional Route of Administration

Roots Analysis

Interestingly, over the past few years, drug developers focused on non-respiratory diseases have also shifted their attention towards intranasal drug formulations. This can be attributed to ease of delivery, increased bioavailability and by-pass of first-pass metabolism offered by this type of route of administration.

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Scilex buys rights to acute migraine treatment Elyxyb in Canada and the US

Pharmaceutical Technology

Elyxyb is a prescription nonsteroidal anti-inflammatory drug (NSAID) used for acute migraine treatment in adult patients with or without aura. It is formulated using a self-micro-emulsifying drug delivery system that improves the drug’s bioavailability and solubility.

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Pharmanovia taps Nanoform to improve bioavailability of ‘iconic branded medicine’

Outsourcing Pharma

The pharmaceutical company has forged a partnership with the nanotechnology specialist to use nanoparticle tech and formulation to advance its products.

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Oral Protein / Peptide-based Drugs: Addressing Key Unmet Needs Across Disease Indications

Roots Analysis

However, it is important to highlight that there are still several challenges which need to be addressed in order to develop biologic drugs capable of effectively being administered via the oral route without undergoing significant losses in specificity and / or bioavailability. Oral Protein / Peptide-based Drugs. Web: [link].

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Vevye: A New Cyclosporine Solution for Dry Eye Disease

XTalks

percent received approval from the US Food and Drug Administration (FDA) to treat dry eye disease. Furthermore, the bioavailability of the active pharmaceutical ingredient (API) into the cornea is up to four times stronger with EyeSol technology. Attendees will understand best practices for novel drug delivery design and development.

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Considerations for Neuroscience Trials with Intrathecal Delivery and Other Methods of Direct CNS Administration

XTalks

According to an analysis of the 2013 Medical Expenditure Panel Survey, one in six US adults reported taking a psychiatric drug at least once in 2013. CNS drugs treat a range of neurologic and psychiatric disorders, such as psychosis, depression, Parkinson’s disease, multiple sclerosis and epilepsy.

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