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The revised term would require a generic drug to contain the same active components in similar dosage forms as its Canadian reference product. Read More
The Canadian government on Wednesday announced a $60 million, seven-year plan to build a massive health database that backers hope will help the country come to grips with its opioid crisis. Read More
Drug sponsors can use complicated covariance analyses to help determine statistical significances or to help sharpen estimates of how well a treatment might work but they shouldn’t apply those analyses to anything in a clinical trial that might be affected by treatment, the FDA says in a new draft guidance document issued Wednesday. Read More
The Federal Trade Commission has filed a lawsuit against Surescripts, alleging that the e-prescription giant created and then ruthlessly protected a monopoly through loyalty provisions in contracts with drug suppliers and pharmacists. Read More
One of the nation’s ten largest drug distributors has agreed to pay $20 million as part of a consent decree with the federal government over felony criminal charges—the first ever targeting a distributor for illegal trafficking of controlled substances. Read More
Australian regulators on Tuesday launched a series of posters to help health providers get consumers ready for upcoming changes to drug labels. Read More
The FDA gave sponsors of combination drug/device products another year to get their IT affairs in order before complying with new postmarket safety reporting requirements. Read More
The FDA released new draft guidance on recalls—urging drugmakers to prepare written recall procedures to help reduce the time consumers are exposed to defective or potentially harmful products. Read More