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Sponsors seeking Canadian approval of new drugs or indications based on published literature or postmarketing data need to be able to prove that their drug is comparable to its reference product, Health Canada says. Read More
Drugmakers should summarize medication errors that don’t result in adverse reactions in periodic safety update reports and in their risk-management plans, the European Medicines Agency says. Read More
The FDA should issue guidance officially adopting U.S. Pharmacopeia standards in its visual particle inspections of injectable drugs, law firm Hogan Lovells says in an April 13 citizen petition submitted to the agency on behalf of an unnamed drugmaker. Read More
Drugmakers operating in New Zealand must begin creating safety signal management processes for every drug they distribute to satisfy the country’s drug regulators. Read More
Homeopathic drugs could face greater regulatory scrutiny by the FDA, as the agency weighs whether its existing regulations and enforcement policies are sufficient to deal with the dramatic uptick in natural products on the U.S. market. Read More
A global regulatory group is following the EU’s lead in recommending that drugmakers use a risk-management approach to qualify and validate manufacturing processes. Read More
To ensure data integrity, drugmakers should implement data controls in their manufacturing processes aligned with the risk to product quality, the Medicines and Healthcare products Regulatory Agency says. Read More
Drugmakers seeking approval of products with hormonal effects should submit an assessment with their applications that evaluates whether they would be harmful if released into the environment. Read More
Reckitt Benckiser is voluntarily recalling 1.5 million units of four varieties of its Mucinex liquid cold medicines nationwide because the back labels may not show they contain acetaminophen and other active ingredients. Read More
Beleaguered Indian generics maker Wockhardt said Tuesday it will recall all remaining batches of 12 to 15 products from the U.S. that were manufactured at its Waluj and Chikalthana, India, plants, due to quality concerns. Read More