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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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FDA Guides On Generic Product-Specific Meetings, Under GDUFA III Commitment

With GDUFA III now almost at the five-month stage, the FDA has released draft guidance on product-specific guidance (PSG) meetings between FDA and a prospective applicant, as part of commitments set forth under the Generic Drug User Fee Act.

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.

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