2006, FDA Approval, Marketing and Regulations

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

FDA Law Blog: Biosimilars

JANUARY 18, 2024

We blogged about CVM last week and explained the increasing attention to animal health products due to the expansion of the animal and pet product market. 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

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]

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

The Pharma Data

MAY 17, 2021

These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .

Research

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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. Following this process, FDASIA directed the FDA to submit a report to Congress summarizing its findings.

FDA

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

Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

Science

Science FDA Clinical Trials Pharmacy

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 Pharma Limited (LSE: OKYO; OTCQB: EMMLF) is a life sciences and biotechnology company admitted to listing on the standard segment of the Official List of the UK Financial Conduct Authority and to trading on the main market for listed securities of London Stock Exchange plc. Enquiries: OKYO Pharma Limited.

Science

Science Virus FDA Approval Treatment

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

Drug & Device Law

JUNE 2, 2022

2012), addressed a challenge to the application of Idaho’s Pain-Capable Unborn Child Protection Act to criminalize the use of an FDA-approved abortifacient medication obtained through an internet prescription and mailed to the plaintiff from out of state. As we discussed here , McCormack v. Hiedeman, 694 F.3d 3d 1004 (9th Cir.

FDA Approval

FDA Approval Pharmacy FDA Drugs

Vaccine Products Liability Claims Preempted

Drug & Device Law

MARCH 22, 2022

The vaccine’s labeling is approved by the FDA and typically a change is allowed only upon FDA approval. Therefore, plaintiff’s failure to warn claim is preempted unless “she has pleaded a labeling deficiency that [defendant] cold have unilaterally changed in accordance with the requirements of the CBE regulation.”

Vaccine

Vaccine Production FDA FDA Approval

The FDA and Feasible Alternative Designs

Drug & Device Law

FEBRUARY 20, 2023

In product liability litigation generally, plaintiffs have been allowed to invent all kinds of “alternative” designs as long as some “expert” opines that the design (even if never before marketed) is “feasible.” Are manufacturers liable only for failing to employ an alternative design that the FDA has approved for distribution. . .

FDA

FDA FDA Approval Testimonials Vaccine

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

Drug & Device Law

MAY 4, 2023

2015), finally gave appellate recognition to the preemption of design defect claims for FDA-approved branded prescription drugs. FDA approved the drug with its particular formulation and the manufacturer could not have changed the formulation on its own. As detailed here , the decision in Yates v. 3d 281 (6th Cir.

FDA Approval

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Drug Discovery Digest

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

Conducting Clinical Studies Under an Investigational Device Exemption

Trending Sources

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

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

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

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

Dobbs Would Likely Have Significant Impacts On Drug And Device Companies

Vaccine Products Liability Claims Preempted

The FDA and Feasible Alternative Designs

Pretty Potent Mix In A Prescription Painkiller Preemption Decision

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