Agency IQ

SEPTEMBER 15, 2023

The change, if adopted by FDA, will have huge implications for consumer options and will challenge the FDA to execute a clear communications rollout. Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs.

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The Pharma Data

MARCH 15, 2022

“Today’s approval of the first generic for one of the most commonly prescribed complex drug-device combination products to treat asthma and COPD is another step forward in our commitment to bring generic copies of complex drugs to the market, which can improve quality of life and help reduce the cost of treatment,” said Sally Choe, Ph.D.,

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Drug Patent Watch

DECEMBER 12, 2024

The generic drug market in the United States faces significant challenges, including price volatility, supply chain disruptions, and strategies employed by brand-name manufacturers to delay market entry. To address these issues, several market-based proposals and regulatory reforms have been suggested.

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The Pharma Data

JULY 29, 2021

Biosimilars marketed in the U.S. With diabetes, the body doesn’t make enough insulin to keep sugar levels regulated in the normal range. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. More than 34 million people in the U.S.

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The Pharma Data

DECEMBER 13, 2020

Food and Drug Administration (FDA) approved a first-of-its-kind intentional genomic alteration (IGA) in a line of domestic pigs, referred to as GalSafe pigs, which may be used for food or human therapeutics. The FDA determined that food from GalSafe pigs is safe for the general population to eat. SILVER SPRING, Md. ,

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The Pharma Data

MAY 13, 2021

A non-opioid pain startup believes it can top the bupivacaine market — and it’s thinking in terms of weeks, not days ( Endpoints ). Regulator seeks views on reclassification of pain medication ( MHRA 1 , 2 ). A Third Rock-backed player charts a new course against transcription factors.

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FDA Law Blog: Biosimilars

JANUARY 4, 2024

The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount.

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Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

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The Pharma Data

OCTOBER 14, 2020

WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled substance by the U.S. WAKIX received FDA approval for the treatment of excessive daytime sleepiness in adult patients with narcolepsy in August 2019.

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KIF1A

JUNE 3, 2023

In past Roundups we’ve discussed how the United States FDA is implementing new strategies to accelerate therapeutic development for rare diseases, reflecting a shift in the culture of drug regulation. Those strategies are now being put into practice for the amyotrophic lateral sclerosis (ALS) community.

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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. .

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FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. Part 1: Multiple PTEs Under the PTE statute at 35 U.S.C. § To that end, 35 U.S.C. § 156(c)(4)

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FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

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FDA Law Blog: Biosimilars

APRIL 21, 2024

Since the PTE statute was created with the September 1984 enactment of the Hatch-Waxman Amendments, and even post-AIA, there have been various instances in which FDA-regulated companies (or their counsel) have failed to timely submit a PTE application to the PTO within the statutory 60-day window ( see, e.g. , here ).

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

Rescheduling Analyses, 2016 DEA noted in 2016 that a drug had a currently accepted medical use for purposes of the CSA if it was the subject of an approved new drug application (“NDA”) under the Federal Food, Drug and Cosmetic Act. FDA, Basis for the Recommendation to Reschedule Marijuana Into Schedule III of the Controlled Substances Act, 3.

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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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Codon

JULY 14, 2024

In 1940, Charles Drew—the first African-American researcher to earn a doctor of medical science degree at Columbia University—developed an ingenious method for separating and storing plasma , the liquid part of blood that contains essential proteins that promote clotting and regulate blood pressure.

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FDA Law Blog: Biosimilars

SEPTEMBER 19, 2023

It merely says that “[t]he Hatch-Waxman Act and FDA regulations set forth the criteria for listing patents in the Orange Book” and that “Brand manufacturers are responsible for ensuring their patents are properly listed.” But it is not always clear which types of patents are eligible for listing in the Orange Book.

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FDA Law Blog: Biosimilars

MAY 15, 2023

By Riëtte van Laack — For those readers unfamiliar with the regulation of animal food ingredients in the United States, below is a brief background. In the United States, animal food (feed) regulations are enforced by state and federal regulatory officials. AAFCO develops model regulations, that serve as model for the states.

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The Pharma Data

JANUARY 27, 2021

Our objective is to work with Bruker and our clinical partners to deliver an effective and high throughput assay protocol, that can be applied in the clinical setting, with the required sensitivity and specificity and CE/FDA approvals to provide a useful additional diagnostic tool in the fight against the coronavirus.

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FDA Law Blog: Biosimilars

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” The “review phase” is the period between the initial submission and approval of the NADA. FDA’s PTE regulations at 21 C.F.R.

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Pharmaceutical Development Group

AUGUST 9, 2021

Offshoring, sophisticated information technology, climate change, and a fresh approach to sales and marketing are all opportunities that the pharmaceutical sector may use. Collaboration with the biotechnology industry is one of the primary opportunities for the pharmaceutical business to remedy this situation.

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Advarra

JANUARY 11, 2024

Many monoclonal antibodies are used to treat cancer by targeting specific cell structures regulating cell activity, causing the death of tumor cells. Immunomodulatory Proteins Immunomodulators are molecules influencing the pathways regulating the body’s immune system activities.

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The Pharma Data

MAY 27, 2022

The FDA approves around 50 new drugs each year after clinical trials and data analyses demonstrate a drug’s safety and effectiveness. To expedite getting potentially beneficial new drugs to seriously ill patients, some of these new drugs are approved through the FDA’s accelerated approval pathway.

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The Pharma Data

NOVEMBER 9, 2021

The State’s claims violate abecedarian principles of due process by seeking to hold a company liable for conduct permitted under civil law and regulations. Food and Drug Administration (FDA)-approved and since launch, have reckoned for lower than one percent of total opioid conventions in Oklahoma as well as the United States.

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The Pharma Data

APRIL 7, 2023

“Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved.” The agency’s approval included a requirement that the sponsor conduct a post marketing confirmatory study.

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Codon

AUGUST 26, 2024

Whereas hydroxychloroquine had already been approved for diseases with established markets, remdesivir lacked approval for any commercially-relevant indication prior to the pandemic. As a result, it is classified as a “drug-free” product and does not require FDA approval.

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Agency IQ

JUNE 7, 2024

dietary supplement market has grown into a vast industry that has little in common with its DSHEA-era predecessor. But despite a recent attempt by the FDA to wrangle the industry into some degree of control, the agency has not followed through on a threat to go after companies that failed to go through a required premarket review process.

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Drug Target Review

DECEMBER 5, 2024

1 In 2017, the US Food and Drug Administration (FDA) approved the first AAV-based gene replacement therapy (Luxturna), for Leber congenital amaurosis type 2. 2 Since then, the FDA has approved four more AAV-based gene therapies—Zolgensma, Hemgenix, Elevidys and Rocktavian—for treating various diseases. Labcompare.

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Pharmaceutical Development Group

OCTOBER 8, 2022

Post EUA documents: EUA issuance does not imply approval or approval from the FDA. You will need the appropriate FDA approval or approval to continue commercializing your product. However, the FDA has not issued an official GMP certification program to acknowledge full compliance.

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been recommended for conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca

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The Pharma Data

JANUARY 29, 2021

29 January 2021 — AstraZeneca’s COVID-19 vaccine has been granted a conditional marketing authorisation (CMA) in the European Union (EU) for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 18 years of age and older. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca.

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Agency IQ

MAY 17, 2024

focuses on marketing exclusivity periods granted to orphan drugs. Following FDA approval, these products are granted seven years of marketing exclusivity, preventing FDA from approving the “same drug for the same disease or condition” if the applicant does not have the right to reference the product (i.e.,

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The Pharma Data

DECEMBER 8, 2020

OSAKA, Japan–( BUSINESS WIRE )– As part of its Wave 1 Pipeline Market Opportunity Call, Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) provided an update on its pipeline portfolio, which has the potential to contribute significantly to revenue growth for the company over the next decade. 9, 2020 00:15 UTC.

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The Pharma Data

DECEMBER 30, 2020

The decision to approve the vaccine was taken under Regulation 174 of the Human Medicine Regulations 2012, which enables rapid emergency regulatory approvals to address significant public health issues such as a pandemic. AZD1222 (SARS-CoV-2 vaccine) FDA Approval History. Source: AstraZeneca. Source link.

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FDA Law Blog: Biosimilars

SEPTEMBER 6, 2023

Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility.

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Codon

MARCH 24, 2024

Novo Nordisk’s market capitalization ($442B) is already larger than the GDP of Denmark ( $404B ), the country where the company is headquartered. The market for semaglutide-based products is projected to swell to $71B in less than a decade. market with Wegovy will, by 2030, require about one million liters of production capacity.

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