2006, Drugs, FDA Approval and Regulations

FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

The Pharma Data

AUGUST 16, 2020

First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.

FDA Approval

FDA Approval FDA Clinical Trials Treatment

From the Porcine to the Ridiculous: Veterinary Drugmaker Sues FDA for Alleged APA Violations

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Palmer — A new lawsuit against FDA is the latest happening in the veterinary drugs space and, by extension, FDA’s Center for Veterinary Medicine (CVM). District Court challenging FDA’s plan to remove their products from the market. Specifically, FDA is looking to remove a drug called carbadox from the market.

FDA

FDA FDA Approval International Production

Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Broadly, the rule sought to require the use of certain safeguards in the production, storage, and use of medical gases.

FDA

FDA Regulations Production Packaging

Drug labeling authority, UDI program reviewed by Harvard-based researchers

The Pharma Data

MAY 17, 2021

The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. .

Research

Research FDA Approval Packaging FDA

Conducting Clinical Studies Under an Investigational Device Exemption

The Premier Consulting Blog

DECEMBER 28, 2023

Under section §812.10, a sponsor may request a waiver of any requirement of the IDE regulations through an application with supporting documentation. The FDA may grant a waiver if the requirement is not stipulated by the Federal Food, Drug, and Cosmetic (FD&C Act) or if it is not necessary for the protection of human subjects. [3]

FDA

FDA FDA Approval Regulations Compliance

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

Agency IQ

SEPTEMBER 15, 2023

FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.

Science

Science FDA Clinical Trials Pharmacy

New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD)

The Pharma Data

SEPTEMBER 9, 2020

ENSPRYNG was recently approved by the U.S. Food and Drug Administration (FDA) for adults with anti-aquaporin-4 (AQP4) antibody positive NMOSD. ENSPRYNG is approved in Canada, Japan, Switzerland and the U.S. Additional applications are under review with numerous regulators, including in the EU and China.

Treatment

Treatment Disease Therapies FDA

OKYO Pharma Limited (“OKYO” or the “Company”) – OKYO announces filing of a patent application covering the use of Chemerin and associated analogues to treat “cytokine storm” associated with COVID-19 and ARDS

The Pharma Data

JANUARY 18, 2021

OKYO has previously announced that it anticipates making an investigational new drug submission with the US Food and Drug Administration for the use of chemerin in the treatment of DED. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014. Gary S. .

Science

Science Virus FDA Approval Treatment

The Lancet Publishes Results from Pivotal Global Phase 3 Program Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis

The Pharma Data

JUNE 18, 2021

FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit [link] or call 1-800-FDA-1088. 2017;34(8):1989–2006.

Treatment

Treatment Disease FDA Vaccine

Importance of Patient-Reported Outcomes in Clinical Trials

Vial

JUNE 12, 2024

Food and Drug Administration (FDA) increasingly look to patients to understand how they describe their health status. PROs, included in clinical trials as primary or secondary endpoints , are increasingly recognized by regulators, clinicians, and patients as valuable tools. From a regulatory standpoint, agencies like the U.S.

Clinical Trials

Clinical Trials Trials FDA Clinical Research

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

Drug & Device Law

JUNE 2, 2022

This has been more than us saying, in essence, that drug and device companies should get to do whatever they want without liability or that any preemption argument should carry the day. This was in contrast to state authority to regulate physicians licensed by the state, as in Planned Parenthood of Cincinnati Region v.

FDA Approval

FDA Approval Pharmacy FDA Drugs

Vaccine Products Liability Claims Preempted

Drug & Device Law

MARCH 22, 2022

The analysis for failure to warn involving a vaccine is the same as for a prescription drug. The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval.

Vaccine

Vaccine Production FDA FDA Approval

Guest Post – Michigan Product Liability Law: Retroactivity of New Law and Primer

Drug & Device Law

FEBRUARY 15, 2024

Today’s guest post is by Sherry Knutson and Brenda Sweet of Tucker Ellis , and concerns the recently passed legislative repeal of a Michigan statute that, for several decades had effectively immunized prescription drugs from ordinary product liability actions under Michigan law. Auto Owners Ins. 2d 277, 286 (Mich. Cartridge Co. ,

Production

Production FDA Approval Compliance FDA

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

But in prescription medical product liability litigation, products must receive FDA approval, clearance or other authorization (hereafter, collectively referred to as “approval” for short) before they can be marketed. to determine whether a proposed alternative drug would have received FDA approval.”

FDA

FDA FDA Approval Testimonials Vaccine

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

Drug & Device Law

MAY 4, 2023

In the show position might be that the temporal relationship between a new medical condition and the use of a drug or medical device does not, without more, prove causation. 2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. 3d 281 (6th Cir.

FDA Approval

FDA Approval FDA Regulations Production

Preemption and OTC Drugs

Drug & Device Law

SEPTEMBER 22, 2023

It is fair to say that Bexis co-founded this blog (in 2006!) Over the years, this blog has come to serve as an important resource for our drug and defense bar colleagues, and Bexis regularly identifies—if not invents—new legal issues and ideas, then proselytizes about them until they become part of the fabric of our legal lives.

Drugs

Drugs Regulations Production FDA Approval

Drug Discovery Digest

FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD)

From the Porcine to the Ridiculous: Veterinary Drugmaker Sues FDA for Alleged APA Violations

Trending Sources

Article FDA Thank You In a new final rule, FDA carves out a regulatory niche for medical gases

Drug labeling authority, UDI program reviewed by Harvard-based researchers

Conducting Clinical Studies Under an Investigational Device Exemption

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

New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD)

OKYO Pharma Limited (“OKYO” or the “Company”) – OKYO announces filing of a patent application covering the use of Chemerin and associated analogues to treat “cytokine storm” associated with COVID-19 and ARDS

The Lancet Publishes Results from Pivotal Global Phase 3 Program Evaluating RINVOQ® (upadacitinib) in Atopic Dermatitis

Importance of Patient-Reported Outcomes in Clinical Trials

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

Vaccine Products Liability Claims Preempted

Guest Post – Michigan Product Liability Law: Retroactivity of New Law and Primer

The FDA and Feasible Alternative Designs

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

Preemption and OTC Drugs

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