News
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New guidance added: ANDA Submissions — Content and Format Guidance for Industry- September 2018
ANDA Submissions — Content and Format Guidance for Industry- September 2018 -
FDA approves first treatment for advanced form of the second most common skin cancer
The USFDA today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) -
Learn all about electronic Drug Registration and Listing
Regulatory Education for Industry (REdI): Electronic Drug Registration and Listing Using CDER Direct: October 2, 2018
