Regulatory Oversight and Compliance

FDA has approved ZTALMY as a treatment for seizures associated with CDKL5 deficiency disorder (CDD).

AstraZeneca’s antibody combination has been authorized for use in Great Britain to prevent COVID-19 in high-risk populations and people for whom vaccination may not be effective.

Olympia Pharmacy is voluntarily recalling eleven lots of seven compounded products due to out-of-specification results.

Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.

Viatris’ new drug-device is the first FDA-approved generic version of AstraZeneca’s Symbicort.

USP is advancing understanding and developing guidance and standards to assist industry in implementing continuous manufacturing.

EMA has recommended that possible side effects of Spikevax and Janssen COVID-19 vaccines be added to product information.

Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control.

Why critical thinking must be applied before technology to ensure regulatory compliance.

Disruptions in the bio/pharmaceutical supply chain can have serious impacts on the quality and availability of life-saving medicines.

Interoperability by 2023 depends on data standardization and systems compatibility between trading partners.

This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.

The US Congress approved a federal spending package that increases funding for a range of programs to advance health and medicine.

C4 Therapeutics has been granted orphan drug designation by FDA for CFT8634 for the treatment of soft tissue sarcoma.

Biotech companies and medical product manufacturers have condemned the invasion of Ukraine, while also looking to maintain supplies of essential medicines.

FDA’s CDER continues to make rare diseases a priority with drug approvals and programming to speed therapeutic development.

EMA’s PRIME scheme has enabled life-changing medicines to become available to patients at a faster rate.

MHRA has awarded Promising Innovation Medicine (PIM) designation to rezafungin for the treatment of invasive candidiasis.

Process performance metrics of eight different mechanical devices were assessed to evaluate compliance with regulatory and compendial criteria.

A consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines.

Continuous improvements in technologies and services will help cold chain operators meet future industry demand.

Pfizer has received Breakthrough Therapy Designation from FDA for its RSV vaccine candidate for prevention of RSV illness in infants by active immunization of pregnant women.

FDA has approved Vonjo (pacritinib) capsules to treat adults with a rare form of bone marrow disorder.

The UK’s National AI Strategy underpins the government’s long-term commitment and ambitions to enhancing the country’s digital ecosystem, with the health and life sciences sectors seen as pivotal contributors to meeting these aims.

Califf will face challenges that include COVID-19, opioids, and user fees.