On This Page Date: October 16, 2024 Time: 1:00 PM – 2:30 PM ET Visit CDER Small Business and Industry Assistance Page ABOUT THIS EVENT (Hosted […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Michael Tursi Recipient Title CEO Stokes Healthcare Inc. dba Epicur Pharma 8000 Commerce Parkway, Suite 600Mount […]

Delivery Method: VIA UPS Reference #: 320-25-05 Product: Drugs Recipient: Recipient Name Ms. Elif M. Diri Recipient Title CEO and Owner Diora Kimya Sanayi ve Ticaret […]

Delivery Method: VIA Electronic Mail Reference #: 320-25-01 Product: Drugs Recipient: Recipient Name Mr. Ravi Srivastava Recipient Title CEO Omni Lens Pvt. Ltd. 5 Samruddhi Ground […]

Delivery Method: VIA Electronic Mail Reference #: 320-25-03 Product: Drugs Recipient: Recipient Name Dr. Hossam Mostafa Recipient Title Managing Director Soliteint Kozmetikai KFT Fot, PestMoricz Zsigmond […]

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended to assist applicants of human prescription drug and biological products in determining […]

On This Page Date: November 20, 2024 Time: 9:00 AM – 12:30 PM ET Location: Event Location FDA HeadquartersFDA headquarters in White Oak, MD 10903 New […]

Information on mandatory reporting: Applicable Regulations You can search the FDA’s CFR Title 21 Database for the latest regulations. The links below will take you directly […]

Regulatory harmonization represents a process where regulatory authorities align technical requirements for the development and marketing of pharmaceutical products. Harmonization of regulatory requirements has many benefits […]