Drug Discovery World

MARCH 29, 2023

What of the increased possibilities for ‘replacement pharmacy compounding’ for weekly hospital supplies, and for routine manufacturing of cell and gene therapies without a marketing authorisation?

Clinical Trials 130

Clinical Trials Pharma Companies Biosimilars Production 130

Agency IQ

JUNE 16, 2023

An update on the Medical Device Quality Management System Regulation : In February 2022, the FDA proposed a new rule which would effectively transition the agency away from its longstanding Quality System Regulation (QSR) in favor of the ISO 13485:2016 standard. Read our analysis of that rule here and here. ]

Regulations 40

Regulations FDA Science Production 40

Agency IQ

DECEMBER 1, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

FDA 40

FDA Science Regulations Production 40

Codon

FEBRUARY 13, 2024

Phage therapies are sold at a pharmacy in Georgia. But what is less well-publicized is that the same 2016 review predicted that the vast majority of these deaths – up to 90 percent – will occur in Africa and Asia, where antibiotic use is soaring and access to alternatives is poor.

Therapies 118

Therapies Virus DNA Clinical Trials 118

Drug & Device Law

DECEMBER 29, 2023

While these five FDA findings (the last in response to the MDL court’s invitation for the FDA to participate directly in this litigation) were nails in these experts’ Rule 702 coffins, they would also support reversing this MDL’s prior adverse preemption decision ( 2016-10 ). The G/N MDL was created in 2013 and mostly settled in 2016.

Testimonials 105

Testimonials FDA Drugs Vaccine 105

Drug & Device Law

JANUARY 4, 2024

115, 125 (2016). Alabama State Board of Pharmacy , 61 F.4th Okuley’s Pharmacy & Home Medical , N.E.3d For “covered persons” and “covered countermeasures” the Act provides extensive preemption: (8) Preemption of State law During the effective period of a declaration. . ., 247d-6d(b)(8). [B]ecause Puerto Rico v.

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59