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The pharmaceutical industry is worried the FDA will hinder the distribution of valid scientific information on off-label drug uses in its new proposal detailing what literature sales reps can distribute to physicians. Read More
Indian drugmaker Wockhardt has received the regulatory green light to resume manufacturing and selling its combination drug to treat pain, the company said April 28. Read More
EU regulators are urging manufacturers of biosimilar insulin-containing products to demonstrate similar pharmacokinetic and pharmacodynamic (PD) profiles as the gold standard in proving efficacy similarity to the reference products. Read More
The European Medicines Agency (EMA) is recommending clinical trial sponsors evaluate local tolerance of medicinal products — i.e., both the active substance and excipient — at contact sites of the body as part of a clinical trial’s general toxicity studies, according to new draft guidance. Read More
Drugmakers should implement and maintain security procedures for electronic safety-and-acknowledgement messages over the internet, according to a European draft guidance that provides technical requirements around online data protection. Read More
Manufacturers should include effective evaluation and verification studies in their process validation documentation when obtaining biotechnology-derived proteins in the EU, according to a new guidance from the European Medicines Agency (EMA). Read More
The FDA on Monday approved UK-based NOVA Laboratories’ oral suspension drug for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination regimen. Read More