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Public health advocates called on the FDA Wednesday to expand access to the opioid overdose reversal drug naloxone by converting it from prescription-only to over-the-counter status. Read More
Public health advocates called on the FDA Wednesday to expand access to the opioid overdose reversal drug naloxone by converting it from prescription-only to over-the-counter status. Read More
The FDA is revoking general safety test requirements that are duplicative in biologics licensing applications and proposing to remove two obsolete regulations for the review and reclassification of biologics licensed before July 1972. Read More
India’s government has announced plans for a $78 million venture capital fund to offer loans to drug companies that are building or expanding manufacturing facilities. Read More
The European Commission says it does not have the power to issue compulsory licenses to allow the manufacture of generic drugs during a health emergency, noting those decisions are made by member states on an individual basis. Read More
The FDA Monday published dozens of product-specific draft guidance documents offering recommendations on the design of bioequivalence studies to support ANDAs. Read More