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FDA Publishes Its Draft Strategy Document on Innovative Manufacturing Technologies

FDA Law Blog

Innovative manufacturing” is a somewhat ill-defined term, but the agency uses it to refer to any novel manufacturing that can increase product development speed, bolster supply chains, or prevent drug shortages. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

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This Thanksgiving, Be Thankful for Family and Food(borne Illness Prevention)

FDA Law Blog

Gaulkin — At the risk of ruining our readers’ appetite for America’s most food-focused holiday, foodborne illnesses have been a feature of Thanksgiving for some time now. When foodborne illness outbreaks arise, efficient traceability is critical to prevent illnesses, death, and unnecessary product loss.

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Analysis of primary care prescription trends in England during the COVID-19 pandemic compared against a predictive model

BMJ

Increased prescribing of certain groups of medications, such as insulin, immunosuppressant drugs, and medications for long-term respiratory illnesses, may hint that these patient groups experienced disproportionate anxiety over medication procurement during the pandemic.

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Hospital-at-Home: Bruce Leff and Tacara Soones

GeriPal

If you are interested in learning more and meeting a community of folks interested in hospital-at-home, check out the hospital-at-home user group at hahusersgroup.org or some of these publications: Hospital-Level Care at Home for Acutely Ill Adults: A Randomized Controlled Trial. How is it financed and what comes next? Annals of Int Med.

Hospital 115
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FDA Approves First State Drug Importation Program Under 20-Year-Old Statute, But High Hurdles Remain

FDA Law Blog

Major Barriers Persist The state plans to start by importing medications for chronic conditions like HIV/AIDS, mental illness, prostate cancer, and urea cycle disorder for patients under the care of its state agencies before expanding the program to Medicaid patients. See 21 C.F.R. 251.5; § 251.6(c). See 21 C.F.R. 251.5; § 251.6(c).