2016, Licensing and Pharmacy - Drug Discovery Digest

Preparing the next generation of drug discovery scientists

Drug Discovery World

NOVEMBER 29, 2022

St George’s, University of London’s Clinical Pharmacology course saw its first graduates this year and has already been named the third best pharmacy and pharmacology course in the UK by the Guardian and is currently the highest ranked pharmacology offering. Providing a broad view.

Clinical Pharmacology

Clinical Pharmacology Clinical Trials Drugs Drug Development

European Commission vs Big Pharma, or profit vs access?

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

Clinical Trials Biosimilars Pharma Companies Production

Federal Marijuana Rescheduling: States Get Ready

FDA Law Blog: Biosimilars

AUGUST 8, 2024

Rescheduling out of schedule I would allow for the medical use of FDA-approved prescription drugs dispensed by DEA-registered, state licensed pharmacies pursuant to prescriptions issued by similarly DEA-registered, state licensed practitioners. Denial of Petition To Initiate Proceedings to Reschedule Marijuana, 81 Fed.

Regulations

Regulations Pharmacy Licensing Licensing

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Agency IQ

AUGUST 16, 2024

The June 2023 guidance recommends that studies involve two monitors (one with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently) to observe study participants during treatment sessions. Lykos (formerly MAPS PBC) met with the agency in 2016 for the End of Phase 2 meeting.

FDA

FDA Trials Regulations Therapies

Article FDA Thank You In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties

Agency IQ

MARCH 25, 2024

FDA addressed the expanding practice of drug compounding in 1992 by issuing a compliance policy guide that clarified that pharmacies which compounded products at certain scales, for certain purposes, or without FDA approval were clearly operating “outside the bounds of traditional pharmacy practice.”

FDA

FDA Pharmacy Production Drugs

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

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

Regulations FDA Science Production

Scaling Phage Therapy

Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. Phage therapies are sold at a pharmacy in Georgia.

Therapies

Therapies Virus DNA Clinical Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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 following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

FDA

FDA Science Regulations Production

Mifepristone Manufacturer Wins First Round in West Virginia

Drug & Device Law

MAY 19, 2023

at *1, by threatening to revoke the license, and jail for at least three years, any West Virginia physician so bold as to prescribe the plaintiff’s FDA-approved drug for its FDA-approved use. In 2016 (during the Obama Administration), the FDA amended this REMS, “expanding those who could be certified to prescribe. . .

FDA Approval

FDA Approval Pharmacy FDA Production

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

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

Testimonials FDA Drugs Vaccine

A Texas Mess

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

Vaccine FDA FDA Approval Pharmacy

Drug Discovery Digest

Preparing the next generation of drug discovery scientists

European Commission vs Big Pharma, or profit vs access?

Trending Sources

Federal Marijuana Rescheduling: States Get Ready

Article FDA Thank You The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways

Article FDA Thank You In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Scaling Phage Therapy

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Mifepristone Manufacturer Wins First Round in West Virginia

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

A Texas Mess

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