Pearls of Wisdom
FDA: remaining proposed and final rules for 2017
According to an updated list of Department of Health and Human Services rulemakings, the US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017. Proposed Rulemakings Among the proposals...
Generic drug approvals on record breaking pace in 2017
After a little more than ten months into Fiscal Year 2017, the US Food and Drug Administration (FDA) is on pace to break its record for abbreviated new drug application (ANDA) approvals from last year.1 FDA has approved 633 generic drugs in FY 2017...
Former CDC Director believes medicine should look beyond randomized controlled trials
Last Thursday, an article was published in the New England Journal of Medicine in which former director of the US Centers for Disease Control and Prevention Thomas Frieden called for greater use of alternative data sources, other than randomized controlled...
Senate passes FDA User Fee Reauthorization Bill
The US Senate on Thursday, August 3rd passed a bipartisan bill to reauthorize the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, medical devices and biosimilars for the next five years.1 According to RAPS, a...
Live webinar covering Japanese medical device approvals from Pearl Pathways’ partner, Brandwood Biomedical- August 15th
On August 15th, join our partner Brandwood Biomedical to learn about the Japanese regulatory process. Prior to the internationally harmonized Japanese Pharmaceutical and Medical Devices Law, the process may have seemed obscure but things aren’t as complex...