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Oligonucleotides, Oxycodone And Osteoarthritis Among 49 US FDA Guidances

A Number Of Oncology Drugs Also Among Raft Of Product Specific Guidances

Executive Summary

The FDA has seemingly followed the lead of the EMA by guiding ANDA sponsors on how to develop oligonucleotide drugs, a complex class of DNA or RNA molecules.

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CDC Advises Against Use Of Extended Release Opioids, Redefines High Dose

New clinical practice guideline recommends immediate-release opioids instead of extended-release and long-acting opioids when starting pain therapy. It specifies high dose is 50 mg morphine equivalent dose (MME) per day or higher. The 2016 guideline had set it at 90 MME/day.

EU Preparing Guidance On Synthetic Oligonucleotides & Peptides

Two new quality guidelines are needed to address the increase in applications for clinical trials and marketing authorizations of oligonucleotide- and peptide-based medicines, says the EU regulator.

FDA Directs On Glenmark’s Ryaltris With New Batch Of Guidances

A batch of four dozen new and revised product-specific guidances for generic products has been published by the US Food and Drug Administration, spanning a range of routes, dosages, and therapeutic areas.

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