Regulatory Oversight and Compliance

FDA is expected to issue Emergency Use Authorization for Moderna’s vaccine, enabling immediate distribution.

The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.

Due to a packaging error, the company is voluntarily recalling one lot of sildenafil 100 mg tablets for the treatment of erectile dysfunction and one lot of trazodone 100mg tablets for the treatment of major depressive disorder.

Trixeo Aerosphere—AstraZeneca’s triple-combination COPD therapy—has been approved for use in the European Union (EU).

EUA marks a milestone in COVID-19 vaccine development and is hailed as a turning point in pandemic fight.

Alternative approaches to training design can better address the desired performance outcomes in a GMP environment while delivering relevant information to meet regulatory compliance.

Success in combatting the pandemic depends on the ability of manufacturers to quickly and efficiently produce and distribute the huge quantities of vaccines demanded by the United States government and public health organizations around the world.

Committee recommends Emergency Use Authorization of first mRNA-based COVID-19 vaccine; FDA approval is pending.

The European Commission has granted a license for the use of inclisiran (Leqvio) as a treatment of primary hypercholesterolemia or mixed dyslipidaemia in adult patients.

Celltrion Healthcare has announced that EMA's CHMP has issued a positive opinion for the marketing authorization of CT-P17—an adalimumab biosimilar.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint strategy for medicines regulation in Europe over the next five years.

The European Medicines Agency has launched a full investigation into a cyberattack.

Pfizer-BioNTech details its case for Emergency Use Authorization for "highly effective" COVID-19 vaccine.

The product is being recalled because of Burkholderia cepecia contamination.

The new guidance document is intended to minimize medication errors and avoid violations of the FD&C Act.

The agency published guidance on how sponsors of combination products can obtain feedback from FDA on scientific and regulatory concerns.

Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.

The COVID-19 pandemic has pushed more pharmaceutical companies and regulators to use new technologies for remote quality audits and inspections.

Industry should improve the standards on application of risk management tools in light of the cases of nitrosamine impurities.

USP is preparing for 2021 while also supporting the development of vaccines and treatments for COVID-19.

The European Pharmacopoeia is preparing for 2021 while also supporting the industry to develop vaccines and treatments for COVID-19.

Pharmaceutical laboratories must keep lab data integrity practices in mind in order to properly handle the effects of the COVID-19 pandemic.

Manufacturers and regulators accelerate R&D and production of new vaccines and therapies.

The success of virtual GMP inspections performed during the pandemic may lead to more flexible opportunities in the future.

After a difficult year, bio/pharma science delivers promising results.

Virtual audits, virtual training, and more robust quality agreements may become positive impacts on the industry, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.

FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19.

The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.

The EC’s approval comes after positive results from seven Phase II and III randomized, active-controlled, multi-center studies.

HMA and EMA have released a joint statement on the appropriate route for companies to submit marketing authorization applications and the approval processes for vaccines.