Crl Records
Browse through 330 crl records and compliance documents. Access detailed regulatory information to stay informed about industry trends and compliance requirements.
Showing 20 of 330 records
Telix Pharmaceuticals (US) Inc.
Product: BLA
Shanghai xuanmei biological science and Technology Co., Ltd.
Product: NDA (New Drug Application)
Office: Center for Drug Evaluation and Research
People: Janet Rea (company_representative)
Alvotech USA, Inc.
Product: BLA
Office: Center for Drug Evaluation and Research
People: Anusha Kesireddy
Rosemont Pharmaceuticals Holdings, Inc.
Product: NDA (New Drug Application)
Office: Center for Drug Evaluation and Research
People: Kristi Norris, PhD
Merck & Co., Inc.
Product: NDA (New Drug Application)
Office: Center for Drug Evaluation and Research
People: Ellis F. Unger, MD
Xspray Pharma AB
Product: NDA (New Drug Application)
Office: Center for Drug Evaluation and Research
People: Jennifer Leaming
Bristol-Myers Squibb Company
Product: NDA (New Drug Application)
Office: Center for Drug Evaluation and Research
People: Amy A. Jennings, Ph.D., Curtis J. Rosebraugh, M.D., M.P.H.
Sentynl Therapeutics, Inc.
Product: NDA (New Drug Application)
Office: Center for Drug Evaluation and Research
People: Eileen P. Banaga
Dr. Reddy’s Laboratories SA (Parexel International)
Product: BLA
Office: Center for Drug Evaluation and Research
People: Ally Danta
AstraZeneca Pharmaceuticals LP
Product: BLA
Office: Center for Drug Evaluation and Research
People: Mohammed Al-Qasmi
NeuroDerm, Ltd.
Product: NDA (New Drug Application)
Office: Center for Drug Evaluation and Research
People: Daniel Solorio
Genzyme Corporation
Product: NDA (New Drug Application)
Office: Center for Drug Evaluation and Research
People: Brant Hamel, PhD, RAC
Corcept Therapeutics Incorporated
Product: NDA (New Drug Application)
Office: Center for Drug Evaluation and Research
People: Christopher Golis
Outlook Therapeutics, Inc.
Product: BLA
Office: Center for Drug Evaluation and Research
People: Jennifer Kissner, PhD
Alvotech USA, Inc.
Product: BLA
Office: Center for Drug Evaluation and Research
People: Anusha Kesireddy
Otsuka Pharmaceutical Company, Ltd.
Product: NDA (New Drug Application)
Office: Office of Drug Evaluation I
SYDNEXIS Inc.
Product: NDA (New Drug Application)
Office: Center for Drug Evaluation and Research
People: Caryn Peterson
MedicaSafe, Inc.
Product: NDA (New Drug Application)
Office: Center for Drug Evaluation and Research
People: Malcolm Dell
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