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Regulators pushing for greater international cooperation cautioned that relying on other countries’ inspections would require overcoming crucial hurdles such as incompatible technology, language barriers and keeping trade secrets secret. Read More
The UK’s National Institute for Health and Care Excellence (NICE) said it will cover Johnson & Johnson subsidiary Janssen-Cilag’s diabetes drug Invokana (canagliflozin) as a treatment for people with type 2 diabetes. Read More
European regulators are advising drugmakers that routine inspections will now include a focus on compliance with pharmacovigilance reporting requirements, and serious violations will face EU Phramacovigilance Risk Assessment Committee (PRAC) review. Read More
The FDA late Friday approved Cubist Pharmaceuticals’ antibiotic Sivextro, the second drug approved for acute bacterial skin and skin structure infections as part of the agency’s effort to encourage the development of new antibiotics as a bulwark against growing drug resistance. Read More
Akorn Enterprises, or its new subsidiary Hi-Tech Pharmacal, was required to sell the marketing rights for five generic drugs to Watson Laboratories to settle federal charges that Akorn’s acquisition of Hi-Tech was anticompetitive, the FTC said. Read More
Australian pharmaceutical regulators have finalized an extensive list of drug products and risk statements that manufacturers of nonprescription drugs should use when changing their labels to meet a requirement that goes into effect at the end of next year. Read More
The FDA and Customs and Border Protection (CBP) began accepting applications for an 18-month pilot of a “trusted trader” program to reduce inspections and oversight of imports from drugmakers that establish tough internal import control programs of their own. Read More
The FDA is making minor changes to its recommendations for companies developing new investigational drugs to treat all types of uncomplicated gonorrhea, expanding eligibility for clinical trial participation to include subjects who are HIV-positive and adopting rapid diagnostic tests to select patients for enrollment. Read More
GPhA is stepping up its opposition to the FDA’s proposed generics labelling rule, releasing a survey that shows more than half of physicians, physician assistants and pharmacists would find the new system confusing for them and their patients. Read More
Drugmakers using Twitter to promote their products need to include both product benefit and risk information in every tweet, despite the 140-character limitations that Twitter imposes on each message, the FDA says. Read More
Two prominent generic drugmakers in Canada won a regulatory victory last month when a federal judge ruled that the country’s regulator of patented medicine prices has no jurisdiction over licensed generic drug pricing. Read More