Quality Systems

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Articles

FDA issued a public statement and press release, along with a sharp warning letter rebuking AcelRx Pharmaceuticals for its messaging on painkiller Dsuvia.

FDA Blasts Misleading Opioid Promotion

The European Medicines Agency announced it has started a review of drugs that contain amfepramone due to concerns that include heart problems and high blood pressure in the lungs.

EMA Reviews Amfepramone Medicines

FDA published recommendations on the use of COVID-19 convalescent plasma or investigational convalescent plasma during the pandemic.

Guidance Issued on Investigational COVID-19 Convalescent Plasma

The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).

EC Approves Celltrion Healthcare’s Adalimumab Biosimilar

The company has pleaded guilty to violating the Federal Food, Drug and Cosmetic Act by failing to provide certain records to FDA investigators and will pay a criminal fine of $30 million, and forfeit an additional $20 million.

Fresenius Kabi Oncology Pleads Guilty to Concealing and Destroying Records Prior to FDA Inspection

Scientists and policy makers are looking more sharply at the lag in identifying and producing medicines to moderate early infections and to treat seriously ill patients. 

Where Are the Therapeutics to Combat COVID-19?

The EC has granted Vico Therapeutics with orphan drug designation for its investigational antisense oligonucleotide therapy for the treatment of SCA.



EC Grants Orphan Drug Designation to Vico Therapeutics’ Oligonucleotide SCA Therapy

The EUA is based on positive results from a Phase III trial that showed bamlanivimab and etesevimab together reduced the risk of COVID-19 hospitalizations and death by 70%.

 FDA Grants Emergency Use Authorization to Eli Lilly COVID-19 Antibody Cocktail

EMA has clarified its position on the European approval process of the Sputnik V vaccine. 

EMA Clarifies Position on Sputnik V European Approval Process

Videos

Pharma companies find ways to maintain quality standards, despite pandemic-related restrictions.

Regulatory Oversight and Compliance