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Bruno Speder is head of clinical regulatory affairs, Clinical Research, SGS Life Science Services, Bruno.Speder@sgs.com.

Articles

A first vaccine against this coronavirus could still take some time to develop, but mRNA vaccine platforms could offer an early breakthrough.

Regulatory Considerations Surrounding Human Challenge Studies with the SARS-CoV-2 Virus

An amendment to Pediatric Research Equity Act, as part of the 2017 FDA Reauthorization Act, goes into effect soon aiming to change the landscape and promote pediatric cancer drug development.  

RACE for Children Act Starts on August 18

Jill Wechsler is ACT's Washington Correspondent

FDA's plans to resume inspections of some US regulated facilities this week are not clear on which sites will be visited and what alternative oversight strategies will apply where on-site inspections are difficult.

Will FDA Inspections Ever Be the Same?

The need for treatments to combat the spread of COVID-19 is promoting greater cooperation among drug regulatory authorities around the world, with FDA officials communicating more frequently with their counterparts in Europe, Canada, Japan and other nations through established programs and agreements.

Global Regulatory Collaborations Aim to Speed Access to New Vaccines & Drugs

The research community is moving quickly to launch clinical trials of potential countermeasures, while regulatory authorities aim to support product development through regulatory flexibility. 

Coronavirus Offers Opportunities and Challenges for Biopharma R&D

FDA’s new commissioner, Stephen Hahn, announced his priorities at an FDA “all hands” staff meeting last week. Jill Wechsler reports.

FDA: Hahn Era Begins

Jill Wechsler is Pharm Exec's Washington Corespondent

While not setting any records for the rapid approval of new drugs in 2019, FDA did speed a number of important new therapies to patients, writes Jill Wechsler.

New Drug Approvals Stay Strong in 2019

FDA’s Office of New Drugs restricting aims to improve scientific exchange and information sharing among review professionals.

FDA Readies Modernized New Drug Review Operation

Examining the unique aspects involved in preparing and submitting marketing applications for proposed treatments for rare disease.  

Submission Considerations for Orphan Product Programs

CDER's Rare Disease Cures Accelerator initiative looks to foster a coordinated research approach and methods that can expedite development of drugs to treat some of the 7,000 rare diseases. 
