Without enough staff at the CDER, which receives user fees ... not replace them," according to a Congressional Research Service document (PDF) explaining the program. With this in mind, the ...

The prescribed dosage for Rezdiffra (resmetirom) may depend on a person’s individual treatment plan. Factors like your medical history and body weight may affect your dosage of Rezdiffra.

The price you pay for Izervay may depend on factors such as whether you have health insurance. Financial assistance may be available to help you with the cost of Izervay. your treatment plan your ...

It will be co-led by Patrizia Cavazzoni, director of the FDA's Centre for Drugs Evaluation and Research (CDER), and Centre for ... according to an advertisement (PDF) posted on the agency's ...

Recent draft guidance highlights the challenges that industry and regulators face to predict rare drug-induced liver injury. At the end of August 2008, the consultation period ended for comments ...

The former CDER leader will succeed Aida Habtezion, M.D., who served as Pfizer’s CMO and head of worldwide medical and safety for four years, and will be leaving the pharma to "pursue other ...

PDF files are ubiquitous in this cross-platform world, making it possible to view and share documents across a range of devices. While simply viewing or commenting on a PDF can be accomplished ...

In my experience, the best PDF editor comes packed with a full suite of features to streamline document creation and management, from clever design tools to security redaction features.

While you can pay for subscriptions and licenses, the best free PDF editor offers all the core tools you need to create and manage documents without paying anything. My team and I have extensively ...

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference ...

It’s not known whether Xcopri (cenobamate) is safe to take while pregnant or breastfeeding. Certain factors, including the risks of not treating your condition during pregnancy, may determine ...