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Reviewing regulatory documents, such as 483 forms and Warning Letters, can aid in determining a facility’s inspection readiness, says Siegfried Schmitt, vice president, Technical at Parexel.
Biologics have specific quality considerations that make fast tracking these drugs more difficult.
Pharmaceuticals are entering a transition into a far more complex era of patient therapies, and patient segmentation.
March 16, 2024
FDA published the draft guidance to support sponsors in developing treatments for the states of sporadic Alzheimer’s disease.
March 08, 2024
EMA has validated two MAAs submitted by AstraZeneca and Daiichi Sankyo for datopotamab deruxtecan in two types of cancer.
The Data Analysis and Real World Interrogation Network, DARWIN EU, is planning to add 10 new data partners in 2024.
March 07, 2024
The agency has published final guidance documents regarding validation and development of analytical procedures.
March 01, 2024
The license holder should negotiate, educate, contract, and then oversee the transportation contractor, says Siegfried Schmitt, vice president, Technical at Parexel.
February 28, 2024
Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.
February 27, 2024
The agency has recommended granting marketing authorization to ALS treatment, Qalsody (tofersen), for adults who have a mutation in the superoxide dismutase 1 (SOD1) gene.
February 23, 2024
Steffen Thirstrup, chief medical officer of the EMA, discusses manufacturing supply, drug shortages, commercial incentives, politics, and patient wellbeing.
February 22, 2024
Daiichi Sankyo is investing approximately €1 billiion (US$1.08 billion) to expand its Pfaffenhofen an der Ilm, Germany, site for ADC development and production.
February 21, 2024
FDA's Drug Safety Priorities FY23 describes the center’s key safety programs and activities involved in promoting and protecting public health.