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By the end of next year the FDA is expected to release rules on drug shortages, biologic safety testing, compounding pharmacy oversight and OTC monographs on cough and cold medicines. Read More
As part of an initiative to increase clinical trial transparency, the FDA has launched a website that provides information about the sex, age, race and ethnicity of participants in studies that support drug approvals. Read More
Merck has gained exclusive licensing rights to an experimental Ebola vaccine that is still undergoing clinical trials under a deal with NewLink Genetics. Read More
The European Medicines Agency has approved an intramuscular long-acting form of Novartis’ Signifor for adults with the rare hormonal disorder acromegaly, which has not been controlled by surgery or older somatostatin analogue (SSA) therapies. Read More
Drugmakers and active pharmaceutical ingredient manufacturers in Europe that produce multiple products in one facility should justify exposure to contaminants and follow specific steps to clean equipment and reduce risks of cross-contamination, according to a new EU guideline. Read More
Generics maker Apotex has sued Health Canada over its ban of the company’s products from India, alleging the agency is enforcing the ban to blunt criticism against it by leaders in parliament and a national newspaper rather than in response to any legitimate quality manufacturing issues. Read More
Future FDA guidances on developing drugs for specific indications will include key milestones to help manufacturers set up their product development programs and guide potential talks with the review division. Read More
The FDA plans to triple its staff in China from 13 to 39, advancing a key agency goal of increasing the number of inspections it conducts in the country, the sixth largest exporter of drugs and biologics to the U.S. Read More