The Pharma Data

NOVEMBER 21, 2021

The FDA approved Voxzogo under the accelerated approval pathway, which allows for earlier approval of drugs that treat serious conditions and fill an unmet medical need, based on a surrogate or intermediate clinical endpoint. Source link: [link].

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The Pharma Data

FEBRUARY 24, 2022

Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. Source link: [link].

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XTalks

JUNE 5, 2023

GLP-1 stimulates insulin production, thus reducing blood glucose levels, and it interacts with the brain to suppress appetite and create a feeling of fullness. As of May 2023, both Ozempic and Wegovy were on the FDA’s Drug Shortages list due to a global shortage of semaglutide. mg and 2.4 mg doses of Wegovy.

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FDA Law Blog

JANUARY 5, 2022

She assists pharmaceutical drug companies of all sizes on product lifecycle management, as well as regulatory strategies related to obtaining FDA approval, exclusivity, and patent listing. Sara also has been heavily involved in FDA-related litigation and interpretation of the Federal Food, Drug, and Cosmetic Act.

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XTalks

MAY 25, 2023

In this episode, Vera talked about the US Food and Drug Administration’s (FDA) approval of Veozah (fezolinetant), the new type of drug for menopausal hot flashes and night sweats. It is estimated that around 60 to 80 percent of women experience vasomotor symptoms (hot flashes, night sweats, etc.)

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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. . Hahn , M.D.

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The Pharma Data

NOVEMBER 23, 2021

Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of mortal and veterinary medicines, vaccines and other natural products for mortal use, and medical bias. Source link: [link].

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FDA Law Blog

JANUARY 5, 2022

She assists pharmaceutical drug companies of all sizes on product lifecycle management, as well as regulatory strategies related to obtaining FDA approval, exclusivity, and patent listing. Sara also has been heavily involved in FDA-related litigation and interpretation of the Federal Food, Drug, and Cosmetic Act.

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Camargo

DECEMBER 13, 2021

The development of biological products (or biologics) represents a major advancement in modern medicine, enabling the treatment of patients with many illnesses where no other therapeutics were previously available. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610.

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FDA Law Blog

APRIL 21, 2024

For purposes of determining the date on which a product receives permission under the second sentence of this paragraph, if such permission is transmitted after 4:30 P.M., Usually at this point in a post we would identify the date of approval of the relevant NDA. That’s important, because PTE applications for U.S.

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Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. This is the first approval of a Section 804 Importation Program ( SIP ) by the FDA. Biologics, controlled substances, and certain other drugs are not eligible for importation.

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Advarra

JULY 26, 2022

In order to understand the current status on cannabis and CBD research studies, it’s important to understand where each product stands. Cannabis and cannabis-derived compounds are treated the same as other FDA-regulated products and subject to the same authorities and requirements. The 2018 Farm Bill.

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Camargo

NOVEMBER 15, 2021

The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). It created the possibility of more easily obtaining information to support new product indications or to help with post-approval study requirements.

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Roots Analysis

JANUARY 3, 2024

Medical aesthetics is a growing area of modern medicine that focuses on improving the cosmetic appearance of an individual through various medical treatments. However, Botulinum toxin was the real game-changer when it was approved for cosmetic use by the FDA in 2002. What is Medical Aesthetics?

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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.” Patients who have questions should talk to their healthcare provider. Source link: [link]

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FDA Law Blog

JUNE 23, 2021

Because no data set is completely reliable in establishing a drug’s benefit, and because no drug is universally effective for all patients, there is inherent uncertainty in every drug approval. The 21st Century Cures Act: Putting Patients First, Literally and … Substantively (And FDA’s New Expanded Access Form) (Feb. 25, 2014).

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FDA Law Blog

MARCH 29, 2023

Richardson — Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent. However, additional naloxone products will remain prescription drugs. launch would be in early 2024. How “accessible” will OTC naloxone really be?

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FDA Law Blog

JANUARY 4, 2024

This unique forum, designed for in-house counsel and executives, as well as private practice attorneys working for the OTC drug industry will provide invaluable insights on FDA’s most recent directives and compliance standards governing OTC drug production, marketing and distribution.

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XTalks

FEBRUARY 16, 2023

However, the company last aired the ad on May 2, 2022, the same day they announced the US Food and Drug Administration (FDA) approval of Quviviq. What Product is Seize the Night and Day Promoting? Quviviq is an FDA-approved prescription medicine that helps treat insomnia in adults, with a low risk of dependence and side effects.

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FDA Law Blog

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise).

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FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S.

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FDA Law Blog

JULY 5, 2023

Palmer — Last week FDA published a long-awaited Draft Guidance for outsourcing facilities addressing the Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act (Draft Guidance). See 21 U.S.C. Section II at 2. More specifically, the prohibition includes when a “third party (e.g.,

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The Pharma Data

DECEMBER 4, 2021

.” With nearly 550 generic medicines available, Teva has the largest portfolio of FDA-approved generic products on the market, and holds the leading position in first-to-file opportunities, with approximately 100 pending first-to-files in the U.S. is filled with a Teva generic product. Source link: [link].

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The Pharma Data

NOVEMBER 20, 2020

Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. Source: FDA. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History.

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FDA Law Blog

AUGUST 16, 2021

A PANDA, or the Pre-Hatch-Waxman Abbreviated New Drug Application, refers to abbreviated drug applications submitted and approved under sections 505(b) and 505(c) of the Federal Food, Drug, and Cosmetic Act (FDCA) prior to the enactment of the Hatch-Waxman Amendments in 1984, as FDA announced in the Federal Register last week.

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The Pharma Data

DECEMBER 18, 2020

. “Guided by science and data, the agency’s career staff determined that the vaccine’s known and potential benefits clearly outweigh its known and potential risks, and although not an FDA approval, the FDA’s expectations described in our June and October guidance documents have been met,” said Peter Marks , M.D.,

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The Pharma Data

APRIL 26, 2022

Learn more about FDA-approved and authorized COVID-19 vaccines. Given the similar course of COVID-19 disease in adults and pediatric patients, today’s approval of Veklury in certain pediatric patients is supported by efficacy results from phase 3 clinical trials in adults. Source link: [link].

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The Pharma Data

NOVEMBER 12, 2021

Treatment is First FDA-Approved Option Patients Can Take Regardless of Previous Therapies. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. Today, the U.S. Source link: [link].

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FDA Law Blog

JULY 8, 2021

Distributed IVD products are regulated by FDA, while laboratories that perform LDTs are regulated by the Centers for Medicare & Medicaid Services (CMS). At various points and in various ways, FDA has sought – mostly unsuccessfully – to regulate LDTs (see here ). Some elements, such as technology certifications, are new.

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FDA Law Blog

MAY 3, 2021

If eligible, the responsible party can delay submission of results information until up to 30 calendar days of (i) the FDA approval or clearance date, (ii) the date that FDA ends the review cycle without approving or clearing the product, or (iii) the date that the submission is withdrawn. 282(j)(5)(A)(iii).

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XTalks

MAY 22, 2023

Allergan Aesthetics, an AbbVie company renowned for its development of leading aesthetics brands and products, recently announced the US Food and Drug Administration (FDA) approved their ground-breaking hyaluronic acid product, SkinVive by Juvéderm, for achieving remarkable skin smoothness.

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FDA Law Blog

MAY 3, 2021

If eligible, the responsible party can delay submission of results information until up to 30 calendar days of (i) the FDA approval or clearance date, (ii) the date that FDA ends the review cycle without approving or clearing the product, or (iii) the date that the submission is withdrawn. 282(j)(5)(A)(iii).

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Advarra

JULY 19, 2022

Do you search for similar products, and use existing IND criteria requirements against the latest manufacturing guidance docs? The sponsor-initiated IND is conducted by a pharma company seeking commercial approval. At what point does the drug substance become a drug product? A: It depends, but the answer is usually yes.

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FDA Law Blog

APRIL 30, 2021

Suitability Petitions permit the submission of an ANDA that differs from an NDA-approved listed drug in strength, dosage form, route of administration, or active ingredient (in a combination drug). But until FDA approves a Suitability Petition, an ANDA cannot be submitted to the Agency for the proposed change.

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FDA Law Blog

APRIL 30, 2021

Suitability Petitions permit the submission of an ANDA that differs from an NDA-approved listed drug in strength, dosage form, route of administration, or active ingredient (in a combination drug). But until FDA approves a Suitability Petition, an ANDA cannot be submitted to the Agency for the proposed change.

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FDA Law Blog

JANUARY 4, 2023

Prescription drug and medical device Pre-Approval Information Exchange (PIE) now has specific legal protection allowing for sponsors to proactively communicate to payors certain information about products in development to help expedite patient access upon product approval. FDA had put industry in a quandary.

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XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities.

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