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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
The FDA’s Office of Pharmaceutical Quality is developing a new inspection protocol that will focus on expert investigator-developed questions and assessment practices. Read More
The FDA is offering two grants of up to $600,000 each over three years in exchange for data to establish statistically based pharmaceutical quality standards — a further sign of the agency’s commitment to using quality metrics. Read More
The Therapeutic Goods Administration is considering raising the maximum limit for classifying rare diseases and specific subsets of patients to broaden the scope of medications that qualify for orphan drug status. Read More
The agency is concerned that the amount and frequency of doses given to patients were subject to investigator discretion and often inconsistent. Read More