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The FDA proposed a new tactic in its fight against the opioid epidemic — blister packs of smaller quantities of opioid drugs that could give providers better prescription options, especially for drugs like Vicodin and Percocet usually intended for short-term use. Read More
The initiative follows previous joint efforts between the two groups that have saved participating drug plans more than CA$1 billion, or about $810 million U.S., in the last five years. Read More
In testimony before a House subcommittee Tuesday, FDA Commissioner Scott Gottlieb told lawmakers the FDA’s plans for regulating compounding pharmacies, including adapting GMP and oversight standards to a facility’s level of risk. Read More
Commonly prescribed generic drugs in Canada will see a price cut of up to 40 percent in April as part of a new initiative announced Monday by two drug industry groups. Read More
Drug sponsors seeking Qualified Infectious Disease Product and fast-track designations for antibiotics must specifically request both designations, according to a new draft guidance from the FDA. Read More
TGA sought feedback on several potential changes to its biologics nomenclature, included introducing suffixes to biological naming conventions, similar to the FDA’s approach, or introducing barcodes to allow traceability of batches, similar to the European Union’s practice. Read More
An Australian Therapeutic Goods Administration proposal to expand the information offered in its current naming system for biologics drew support from most respondents, with Mylan warning an alternate proposal to adopt suffixes may offer little benefit for pharmacovigilance. Read More
A federal judge ruled that the FDA’s denial of exclusivity of a generic version of Namenda XR was lawful, writing that the agency’s request for more information from an ANDA applicant does not constitute a new regulatory hurdle. Read More
A District of Columbia court partially ruled against Amgen in a dispute with the FDA over what the company called inconsistent agency approvals of pediatric exclusivity. Read More