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Pending industry user fee reauthorization will strongly shape the FDA’s likely effort to use regulatory action to preempt legislative fixes for a number of issues in the next Congress, sources say.
The outgoing chairman of the Senate committee with jurisdiction over the FDA is calling on his colleagues to confirm Andrew von Eschenbach as the commissioner of the FDA before the end of the 109th Congress to provide the leadership necessary to change what he calls an agency in turmoil.
With the Democrats taking control of the Senate, the healthcare agenda will likely focus on increasing the availability of generics in the market, improved drug safety and the role of trade policy in protecting domestic pharmaceuticals, according to industry observers.
The FDA is looking into ultimately moving to an all-electronic submission system for regulatory information in all its divisions and will hold a public hearing on the proposal next month.
The outgoing chairman of the Senate committee with jurisdiction over the FDA is calling on his colleagues to confirm Andrew von Eschenbach as the commissioner of the FDA before the end of the 109th Congress to provide the leadership necessary to change what he calls an agency in turmoil.
In an effort to help pharmaceutical manufacturers evaluate test results, the FDA is issuing a new guidance on investigating out-of-specification (OOS) results that fall outside the acceptance criteria established in drug applications, drug master files, official compendia or by the manufacturer.
The intercenter agreements (ICAs) governing how combination and single-entity products are assigned to FDA centers have become incomplete statements due to a slew of emerging products and the large volume of jurisdictional decisions the agency has made in recent years, the FDA said.
In an effort to help biologic product manufacturers report deviations from current good manufacturing practices (cGMPs), the FDA issued a guidance detailing the correct steps to take when an event occurs that may affect the safety, purity or potency of products.