Drugs

HHS Outlines FDA Projects Under Biotech Initiative

HHS has outlined specific FDA projects that will be undertaken as part of President Biden’s recent Executive Order launching a National Biotechnology and Biomanufacturing Initiative (NBBI). According to the department, NBBI will “help drive research and development, improve access to quality federal data, grow domestic manufacturing capacity, expand market opportunities for biobased products, train a diverse and skilled workforce, streamline regulatory processes for products of biotechnology, advance biosafety and biosecurity to reduce risk, protect the U.S. biotechnology ecosystem, and build a thriving and secure global bioeconomy with partners and allies.”

Under the initiative, HHS says it will

Support FDA research programs for advanced manufacturing technologies at CDER and CBER, "fueling multiple intramural and extramural research projects (e.g., smart data analytics and novel process analytic technology for bioprocessing, and continuous manufacturing of biological products) to build a knowledge base in support of regulatory assessment, as well as scientific standard, guidance, and policy development.”
Develop an Advanced Manufacturing Innovation Hub at FDA’s Office of Counterterrorism and Emerging Threats to create regulatory science benchmarks and strategies for platform technologies and to advance collaborations for “smart manufacturing, closed loop process controls.”
Support development of an FDA Center for Advancement of Manufacturing Pharmaceuticals and Biopharmaceuticals to coordinate and collaborate science, regulatory, and policy activities between CDER and CBER.
Support additional pre-submission support at CDER/CBER/CDRH for applicants looking to adopt advanced manufacturing technologies.
Support more harmonizing requirements to promote innovation, including developing an ICH Q13 guideline on continuous manufacturing of drug substances and drug products, an ICH Q5A guideline on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, and an ICH Q14 guideline on analytical procedure development.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome