Article, FDA Approval and Pharmacy - Drug Discovery Digest

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.”

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Article FDA Thank You Addressing benzene contamination, FDA issues guidance for reformulating products containing certain carbomers

Agency IQ

JANUARY 4, 2024

Citizen petitions have raised the alarm regarding benzene in recent years, leading to FDA action Valisure, an analytical pharmacy that first alerted the FDA to concerns associated with nitrosamine impurities , recently set its sights on benzene impurities.

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. CHPA considered the original studies to be sound and instead found issues with the newer studies.

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Bridging Innovation & Patient Care: The Growing Role of AI

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New JAMA Article Recommends Personal Drug Importation To Help American Patients Afford Prescription Drugs

Policy Prescription

OCTOBER 22, 2024

Harvard doctors and public health experts recommend using the website PharmacyChecker.com to find international online pharmacies to order more affordable prescription drugs for personal importation when domestic savings strategies fail. They offer this advice in a new article in the Journal of the American Medical Association.

Online Pharmacies

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Mark Cuban’s Pharmacy Dreams Are Generic

Policy Prescription

FEBRUARY 9, 2022

Mark Cuban’s new online pharmacy venture – the Mark Cuban Cost Plus Drug Company (“Cost Plus Drug”) – will not help overcome the biggest obstacle to drug affordability in America, which is drug company monopolies on patented brand name prescription drugs. That’s even cheaper than foreign online pharmacy prices , including in India. .

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FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients

The Pharma Data

NOVEMBER 8, 2020

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients. Food and Drug Administration (FDA) has approved Sesquient (fosphenytoin sodium for injection) for the treatment of status epilepticus in adult and pediatric patients. About Sesquient. Source link.

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FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

The Pharma Data

NOVEMBER 20, 2020

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies. Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company’s first FDA approval. PALO ALTO, Calif.,

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Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Agency IQ

JANUARY 26, 2024

Such a situation is commonplace in the clinical trial realm, in which investigational drug products which are not already FDA approved are administered to patients. Under the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) , the FDA also has some authority to extend MCM expiration dates.

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Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Agency IQ

OCTOBER 20, 2023

” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. It is also unclear how the pilot program will collide with a recent publication from FDA scientists regarding the usefulness of biosimilar “switching” studies.

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

Agency IQ

JUNE 16, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

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

Agency IQ

OCTOBER 27, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B. What ever happened to that thing?

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

Agency IQ

SEPTEMBER 29, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

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Article FDA Thank You In unanimous decision, Supreme Court solves FDA’s ‘standing’ issue

Agency IQ

JUNE 17, 2024

Under Article III of the Constitution , a party must have “standing” to challenge a rule or law. Plaintiffs lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone,” the court wrote. None of these theories suffices to establish Article III standing,” the court added.

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

Agency IQ

DECEMBER 1, 2023

FDA is proposing to establish the criteria by which it would evaluate drug products and categories of drug products for inclusion on the list of drug products and categories of drug products that present demonstrable difficulties for compounding under section 503A and/or under section 503B.

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Medicare Coverage Analysis Worksheet

Advarra

DECEMBER 14, 2022

Pharmacy manual. Approval letter from the Centers for Medicare & Medicaid Services (CMS), including investigational device exemption (IDE) devices. FDA-approved IDE devices may be deemed qualifying under the Medicare Benefit Policy Manual, Chapter 14. Optional Documents. Clinical trial agreement. Lab manual.

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

Drug & Device Law

DECEMBER 29, 2023

2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) ( here ); National Association of Wheat Growers v. The FDA requires real science for warnings; thus it had not mandated any warning remotely resembling Prop 65. C-8 Personal Injury Litigation , 87 F.4th 4th 315 (6th Cir.

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Mifepristone Manufacturer Wins First Round in West Virginia

Drug & Device Law

MAY 19, 2023

Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom Frontier” – which will soon be published in the Food & Drug Law Journal. A draft of this article is now available on SSRN. In GenBioPro, Inc.

FDA Approval

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Drug Discovery Digest

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

Article FDA Thank You Addressing benzene contamination, FDA issues guidance for reformulating products containing certain carbomers

Webinars

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Webinars

New JAMA Article Recommends Personal Drug Importation To Help American Patients Afford Prescription Drugs

Mark Cuban’s Pharmacy Dreams Are Generic

FDA Approves Sesquient (fosphenytoin sodium) for the Treatment of Status Epilepticus in Adult and Pediatric Patients

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

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

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

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

Article FDA Thank You In unanimous decision, Supreme Court solves FDA’s ‘standing’ issue

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

Medicare Coverage Analysis Worksheet

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

Mifepristone Manufacturer Wins First Round in West Virginia

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