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The European Medicines Agency plans to launch an improved version of its adverse event monitoring system, EudraVigilance, in November, with new methods for reporting and analyzing suspected reactions to investigational and authorized products. Read More
Fifty-two representatives and nine senators sent letters to HHS Secretary Tom Price and CMS Administrator Seema Verma, urging them to reverse current Medicare policy for the reimbursement for biosimilar products. Read More
Scott Gottlieb was sworn in as the 23rd FDA commissioner May 11, with plans to face the nationwide opioid crisis, which he has called the agency’s number one challenge, and outlined his vision for a more risk-based, patient-centric organization. Read More
The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure Monday, aligning inspection staff into seven product categories — more closely mirroring the organization of the agency’s centers. Read More
House and Senate panels proceeded with advancing the FDA user fee reauthorization package last month, even while Trump and HHS called for negotiations on the amounts paid by industry to be reopened — and nearly doubled. Read More
President Donald Trump’s executive order on new regulations will likely lead to increased use of internal communications to make drug policy at the FDA, an expert said at an FDAnews conference on drug-device combination products last week. Read More
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