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The Australian Therapeutic Goods Administration issued an industry guidance proposing to quickly approve certain types of low-risk variations to registered medicines without requiring evaluation, allowing sponsors to implement the changes immediately. Read More
The 21st Century Cures Act represents a “missed opportunity” to clarify the distinction between a drug and a device and improve transparency, according to experts at a June 8 conference sponsored by FDAnews in Washington D.C. Thursday on combination products. Read More
FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure in mid-May, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers and ultimately moving to what may seem like stricter inspections, especially at first. Read More
The FDA is planning to transition to a new drug development tool qualification process — as required by the 21st Century Cures Act — for clearing the use of biomarkers, clinical outcomes assessments and other methods to aid regulatory review. Read More
The FDA requested that Endo Pharmaceuticals voluntarily remove its opioid painkiller Opana ER from the market, saying its benefits may no longer outweigh its risks of abuse — the first time the agency has taken steps to remove a currently marketed opioid from sale. Read More
The House Energy and Commerce Committee voted 54-0 on Wednesday to advance the FDA’s five-year user fee reauthorization package to the floor of the House — following a lengthy debate, more on the rising cost of prescription drugs than on the fee programs at the heart of the bill. Read More
The World Health Organization published its biennial update to its list of essential medicines, adding therapies for hepatitis C, HIV and leukemia, as well as new advice on combating antimicrobial drug resistance. Read More