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Australia’s Therapeutic Goods Administration (TGA) is asking for feedback on changes it’s considering for its generic drug market authorization process — including the potential use of foreign reference products to show bioequivalence. Read More
Petitions aimed at delaying approvals of competing drugs are diverting resources away from the agency’s public health efforts, the FDA said in a report to Congress. Read More
The prescribing doctor argued that none of the additional risk information would have changed his decision to prescribe Pradaxa to the patient. Read More
In a letter to the company, Sanders claimed the drug only costs up to $6,000 to make and accused Catalyst of “corporate greed” that is “threatening access … and handing a completely unwarranted bill to American taxpayers.” Read More
The FDA released a new manual of policies and procedures (MAPP) for developing a shared system risk evaluation and mitigation strategy (REMS). Read More
A federal court this week entered a consent decree against a Pennsylvania compounder for manufacturing purportedly sterile drugs in insanitary conditions. Read More
The FDA released draft guidance on clinical trial designs for treatments of eosinophilic esophagitis (EoE), a chronic inflammatory disease, including recommendations for selecting trial participants. Read More
The FDA issued a warning to Lymol Medical for failing to submit a final postmarketing requirement (PMR) report on its sterile talc product without providing a good explanation for the delay. Read More