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The U.K.’s Medicines and Healthcare products Regulatory Agency released new guidance on its approach to GXP data integrity and its expectations for achieving compliance. Read More
Australia’s Therapeutic Goods Administration will impose heavier sanctions for violations of its regulations on drug advertising, but the agency also will phase out its requirement that certain drug advertisements be pre-approved in favor of a more self-regulated rule. Read More
Health Canada adopted the ICH’s Q&A guideline on the development and manufacture of drug substances as well as a separate guidance on residual solvents. Read More
The Chinese government unveiled a new policy whereby some generics manufacturers could qualify for a “high-tech enterprise” designation, making them subject to a 15 percent corporate tax rate compared to the 25 percent rate paid by other companies. Read More
The FDA adopted an addendum updating the ICH’s E11 guideline on pediatric clinical trials, outlining ethical considerations, age classifications, pediatric drug formulations, practicalities in clinical trials and approaches to optimizing drug development. Read More
A European Medicines Agency report states that 944 API manufacturers were inspected in the first six years of the International Active Pharmaceutical Ingredient Inspection Program. Read More
The European Commission issued revised guidance for regulatory authorities, marketing authorization applicants and holders on the listing of excipients on product labeling and package leaflets. Read More
Participants in the discussion will include the directors of advocacy groups, recovering addicts and those who have lost family members to addiction. Read More
Sen. Hatch said the bill would cut red tape to ensure manufacturers of non-opioid pain medications can bring them to market as quickly as possible. Read More
In the latest addition to the swirl of opioid-related bills circulating on Capitol Hill, four senators introduced legislation to require the FDA to issue guidance on how breakthrough and accelerated approval designations apply to novel, non-opioid or non-addictive pain medications. Read More