Quality Systems

Articles

The EC has launched a structured dialogue aimed at gaining a better understanding of global medicines supply chains and to identify potential causes and drivers of vulnerabilities.

EC Launches Structured Dialogue to Address Medicines Supply Vulnerabilities

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

Reviews of FDA initiatives and activities recapitulate efforts to assess and approve new drugs, generic drugs, and biologics and strategies for advancing new initiatives.

FDA Documents Achievements and Plans for Future

Sean Milmo is a freelance writer based in Essex, UK.

The UK government is taking advantage of the new regulatory flexibility, afforded by Brexit, to boost the country’s competitiveness in pharma.

Adapting Regulations Post-Brexit

FDA moves recommended timeline for API and drug manufacturers to assess impurity risks to March 31, 2021.

Nitrosamine Risk Assessment Date Extended

Distribution of the first one-dose vaccine for COVID-19 to start in early March.

J&J Vaccine Approved for Emergency Use

To prevent future production delays of critical products, the Biden administration is examining supply chain vulnerabilities for pharmaceutical ingredients as part of a longer-range consideration of products important to public health. 

COVID-19 Vaccine Makers Overcome Challenges to Ramp Up Production

New data shows that the COVID-19 vaccines can be stored at standard freezer temperatures for up to two weeks.

Pfizer and BioNTech Submit New Vaccine Stability Data to FDA

The agency issued guidance for developers of vaccines, diagnostics, and therapeutics to address variants of the COVID-19 virus.

FDA Gives Guidance on COVID-19 Variants

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.

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