FDA to review FHC's premarket approval application for female condom - Pharmaceutical Business review

Pharmaceutical Business review is using cookies

07 Feb 2008

News

FDA to review FHC’s premarket approval application for female condom

The Female Health Company has announced that the FDA has accepted to review the premarket approval application of the company's second generation product, FC2 female condom.

The Center for Devices and Radiological Health (CDRH) received Female Health Company’s (FHC) PMA on January 8, 2008.

Drug Discovery

Research & Development

PrimeGen US and DT Cloud Star sign $1.5bn merger agreement

Relay Therapeutics’ zovegalisib secures FDA BTD for advanced breast cancer

Clinical Trials

Patient Enrollment

US FDA approves Avacta Group’s IND application for AVA6000

AM-Pharma enrols first patients in Covid-19 phase III trial

Regulation

Drug Filing

Viatris files applications in Japan for approval of Effexor to treat GAD

Scholar Rock submits application of SMA therapy to FDA

Production & Sales

Manufacturing

ENCell and Lucy Biotech forge alliance for mesenchymal stem cell therapy

Merck introduces single-use reactor to accelerate ADC manufacturing

Packaging & Supply Chain

Packaging

Gerresheimer at CPHI Frankfurt 2025

Gerresheimer

Suppliers

No data found