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Best CDMO Practices for Startups: Navigating the Complex World of Contract Development and Manufacturing

Drug Patent Watch

In 2017, small and medium-sized biotech companies accounted for 51% of FDA market approvals, while large pharma companies were the originators in only 28% of approvals[4]. Take the time to clearly define your technical needs, from drug substance manufacturing to packaging requirements. A: Regular audits and open communication are key.

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A Visual Guide to Genome Editors

Codon

pyogenes protein — whose compactness makes them far easier to package into viral vectors and deliver into the human body. For example, one can fuse a deactivated Cas9 protein to so-called “transcriptional regulators” to either activate or repress genes without directly editing the genome at all.

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AZVUDINE

New Drug Approvals

Detailed numbers are provided by Genuine in the slides and the medication package insert. [14] 22] In the same month, China’s drug regulator (NMPA) decided to fast-track the approval process, labelling it a first-in-class medication. [14] July 2017). 17] Azvudine is toxic to the reproductive system of rats and rabbit.

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Article Periodic Thank You Commission unveils “one substance, one assessment” reform package

Agency IQ

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. With the publication of three proposed legal acts, this concept is one step closer to streamlining the way the bloc regulates chemicals.

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Analysis Chemical Thank You PFAS regulation in California (late 2023 edition)

Agency IQ

PFAS regulation in California (late 2023 edition) California consistently maintains its status as both one of the most important economies in the world as well as one of the most regulated states in the United States. In 2019, the state began to significantly ramp up its PFAS regulation and research.

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Article Periodic Thank You Swiss regulators align with EU on chemicals, biocides

Agency IQ

Swiss regulators align with EU on chemicals, biocides The Swiss Notification Authority for Chemicals has announced new adaptations are in the offing that will harmonize parts of the Swiss Chemicals and Biocidal Products ordinances with recent updates to corresponding EU legislation.

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Article EMA Thank You EMA publishes first electronic Product Information as pilot progresses

Agency IQ

A 2017 European Commission report ( EMA presentation ) highlighted various areas for improvement of product information (e.g., readability of package leaflet, patient engagement). The summary of Product Characteristics (SmPC) and the Package Leaflet (PL) are the main target for digitalization.