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A California appeals court revived a lawsuit against GlaxoSmithKline in which the plaintiffs claimed the company failed to properly warn non-English speakers about the risks of its antidiabetic drug Avandia (rosiglitazone). Read More
Drug manufacturers found to be fueling the opioid crisis would face marketing limitations and stiff fines under legislation introduced by Sen. Bernie Sanders (I-Vt.). Read More
The Drug Enforcement Administration proposes to limit the production of opioids when setting production quotas by taking into account how often the prescribed drugs are illegally diverted from the individuals for whom they were prescribed. Read More
The EU reassigned oversight of more than 370 centrally authorized drugs from UK agencies to other EU member states in anticipation of Brexit. Read More
CDER’s Office of New Drugs issued a new manual of policies and procedures, effective immediately, concerning NDAs for parenteral drugs that will be packaged in plastic immediate containers. Read More
Potential or actual impurities in drugs should be studied for their mutagenic properties, according to a revision to an ICH guideline addendum on mutagenic carcinogens, now adopted by the FDA. Read More
In its first ever annual report, the FDA’s Office of Pharmaceutical Quality highlighted its main accomplishments in 2017 and noted it faced major challenges with more than 100 of its 1,300 officers deployed for inspections in the aftermaths of Hurricanes Harvey, Irma and Maria. Read More
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