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© 2021 MJH Life Sciences and BioPharm International. All rights reserved.
© 2021 MJH Life Sciences™ and BioPharm International. All rights reserved.
April 09, 2021
Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.
April 01, 2021
Scrutiny of the vulnerability in the biopharmaceutical supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities.
March 29, 2021
The agency’s human medicines committee has approved new manufacturing sites for COVID-19 vaccines.
March 24, 2021
Is FDA approving too many new drugs and added indications too quickly based on surrogate endpoints that fail to pan out?
March 19, 2021
BIA has released comments urging the UK government to take a science-based approach to the regulatory framework for gene editing and GMOs.
March 16, 2021
Many biologic drug manufacturers encounter similiar challenges; precompetitive collaboration can help resolve these issues. Representatives of the IQ Consortium’s Biologics CMC Leadership Group describe efforts to address the safe handling of biologic drugs in closed-system transfer devices in healthcare settings and the need for phase-appropriate specifications.
Extrapolating data from adult clinical trials to a pediatric population is a proven method to avoid unnecessary pediatric clinical trials. Representatives of the Pediatric Working Group of the IQ Consortium share case studies that demonstrate how adult clinical trial data can be used to support the dose selection and regimen—or waive the need for a placebo control arm—for pediatric studies.
Maintaining a quality culture across the diverse functions in a bio/pharmaceutical company is difficult. Representatives of the Quality Coordinating Committee of IQ Consortium report on collaborative efforts to address data integrity and the modernization of FDA’s good laboratory practice regulations.
A plant inspection backlog caused by COVID-19 restrictions threatens innovation and public health. Now pressured to step up on-site inspections, will FDA embrace new methods?
March 15, 2021
FDA’s newly proposed draft guidance will support IND filings of antisense oligonucleotides, a new class of drugs.