Regulatory Oversight and Compliance

Unpacking COVID-19 Pandemic Response

August 10, 2023

Highlights from a wide ranging discussion on COVID-19 pandemic response from Kate Broderick, Chief Innovation Officer at Maravai LifeSciences, and Tom Madden, President & CEO at Acuitas Therapeutics.

Sparian Biosciences Awarded Five-Year NIH/NDA Grant for Development of SBS-518

August 09, 2023

SBS-518 is a first-in-class dual sigma receptor (SR) antagonist/dopamine transporter (DAT) inhibitor in development for the treatment of stimulant use disorder (StUD).

FDA Grants Orphan Drug Designation to Treatment of Malignant Glioma

August 08, 2023

The investigational drug was developed to activate a novel uptake pathway, allowing antineoplastic drugs to combat solid tumors more successfully.

FDA Warns that Tydemy May Have Reduced Effectiveness

August 08, 2023

Lower levels of an active ingredient may result in unexpected pregnancies.

FDA Approves OTC Opioid Overdose Treatment

August 03, 2023

The nasal-spray drug can be used to reverse the effects of opioid overdose.

Ensuring OSD Quality and Safety

August 02, 2023

Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.

Phasing Out COVID-19 Regulatory Flexibilities

August 02, 2023

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

Industry Challenges Medicare Price Negotiation Scheme

August 02, 2023

Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.

Exploring an Intelligent Drug Development Paradigm

August 02, 2023

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

FDA Releases Guidance on Standards Related to Pharmaceutical Quality

August 01, 2023

The program aims to aid submissions from external stakeholders and FDA staff.