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Clinical studies evaluating the safety and tolerability of vaginal microbicide gels to prevent HIV infections should use a scoring system to measure the presence and severity of rash, swelling, immune response and damage to local tissue, FDA final guidance says. Read More
German regulators have published a list of 80 generic medicines whose approvals were yanked after EU authorities expressed concerns with contract research organization GVK Biosciences. Read More
GPhA is pushing for more states to pass automatic biosimilar substitution laws next year using draft language that eliminates requirements to notify prescribers of a swap with the brand. Read More
Manufacturers of therapies in Japan that combine drugs with either a medical device or a cellular or tissue-based product must determine which category it falls under before filing a marketing application, according to a revised regulation. Read More
Ebola vaccine manufacturers Janssen, GlaxoSmithKline and NewLink Genetics will be sheltered from legal liability under a law that protects companies that produce treatments to combat public health emergencies, HHS said yesterday. Read More
Starting next year, pharmaceutical wholesale distributors must submit annual reports that include detailed contact and state licensure information as well as any significant disciplinary actions taken by state or federal officials, the FDA says. Read More
Sponsors submitting pediatric study plans for a drug have several options to determine optimal dosing for children when no standard dosing information exists, according to an FDA draft guidance on clinical pharmacology in pediatric studies. Read More
In a preview of how the FDA’s Office of Pharmaceutical Quality will speed approval of generic drugs, the office is rolling out a framework for ANDA filers to respond to minor agency queries involving chemistry, manufacturing and control issues early in the review cycle. Read More