FDA Law Blog

MAY 3, 2021

The CSA establishes a closed system of controlled substance distribution that requires every entity in the chain, from importers to manufacturers, distributors, exporters, pharmacies, hospitals, narcotic treatment programs and practitioners, to obtain a DEA registration and account for the controlled substances they handle. 21 U.S.C. §

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Compliance Pharmacy Regulation Manufacturing 40

XTalks

MARCH 28, 2024

The US Food and Drug Administration (FDA) has given the nod to Winrevair (sotatercept-csrk injection, 45mg, 60mg) for the treatment of adults with pulmonary arterial hypertension (PAH) to increase exercise capacity, improve WHO (World Health Organization) functional class (FC) and reduce the risk of clinical worsening events.

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The Pharma Data

MAY 7, 2021

Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ). Massachusetts sues Publicis for designing ‘marketing schemes’ to boost OxyContin sales ( STAT ). WHO approves emergency use of China’s Sinopharm Covid vaccine ( FT ). What happens now?

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Vaccination Vaccine Drugs Regulation 52

Pharmacy Checkers

OCTOBER 2, 2020

Unlike wholesale importation, Section 804 does not legalize personal importation from Canada or other countries, but it does permit it through enforcement discretion, regulation or waiver. They do so by buying directly from pharmacies in other countries. Personal importation is directly importing from a pharmacy in Canada.

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Pharmacy Drugs FDA Approval Cosmetics 54

The Pharma Data

JANUARY 24, 2021

The Company owns 80% of Pharmadrug GmbH, a German medical cannabis distributor, with a Schedule I European Union narcotics license and German EuGMP certification allowing for the importation and distribution of medical cannabis to pharmacies in Germany and throughout the EU.

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XTalks

JUNE 12, 2023

Abbott Laboratories reported that the sales from its Diagnostics and Medical Device divisions in 2022 surpassed the company’s initial forecast. The remarkable performance in 2022 was driven largely by the sales of COVID-19 testing kits, including the BinaxNOW COVID-19 Ag test and its at-home self-test version. percent from $27.06

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FDA Approval Production Sales In-Vitro 98

pharmaphorum

OCTOBER 19, 2021

Biosimilar competition to AbbVie’s big-selling Humira drug in the US has just been ratcheted up by the FDA approval of Boehringer Ingelheim’s Cyltezo – which can be substituted for the reference drug without any prescriber intervention.

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Sales Production Insulin FDA Approval 40

XTalks

MARCH 22, 2023

To celebrate this milestone, we’re taking a look back over the last 20 years in the pharmaceutical industry by highlighting some of the most talked-about mergers, blockbuster drugs, trends in FDA approvals and what’s next. More potential patients equal more prescriptions which equals higher sales and bigger profits.

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Life Science Drugs FDA Approval Vaccination 97

pharmaphorum

DECEMBER 28, 2022

The bipartisan PIE Act was tabled in March by lawmakers led by Representatives Brett Guthrie (R-KY) and Anna Eshoo (D-CA), both leaders of the Energy & Commerce Health Subcommittee, and will allow manufacturers to share vital information with healthcare payers and plans while treatments are pending FDA approval.

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FDA Approval Manufacturing Pharmacy Clinical Trials 52

XTalks

AUGUST 30, 2022

Global sales of over-the-counter and prescription products related to central nervous system (CNS) disease added up to $86 billion in 2019. Direct CNS administration is also FDA-approved for multiple small molecules and ASOs. Targeting the CNS directly has been successful in modern medicine.

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Trials Drug Delivery Drugs Gene 83

The Pharma Data

MAY 13, 2021

I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! Which is how I got into pharmacy — after all, what better way to spend your life than by removing illness from the world. . … And then got my Doctor of Pharmacy (Pharm.

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Pharmacy Production Doctors Doctor 52

Pharmacy Checkers

JANUARY 4, 2020

It’s a major milestone that the FDA is willing to and on the cusp of finally providing that certification – but that’s only for wholesale importation. Wholesale drug importation is when people or companies import drugs for re-sale, usually described as commercial quantities. Those pharmacies aren’t rogue. That is a problem.

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Drugs Pharmacy Medicine Regulation 58

Pharmacy Checkers

FEBRUARY 21, 2020

On behalf of Prescription Justice, I submitted comments to the FDA in response to its request for public comments on its draft guidance called: “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”.

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Drugs FDA Approval Manufacturing Pharmacy 61

Pharmaceutical Technology

APRIL 24, 2023

Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995.

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Drug Delivery Vaccination Vaccine Research 147

Pharmacy Checkers

MARCH 11, 2020

Founded in 2002, and launching its website in 2003, PharmacyChecker provides consumers with online pharmacy verification and comparative drug price information to help them make the best decisions for themselves and their families on how to afford prescription drugs. counterparts. Part J is written in three sections.

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Pharmacy Drugs FDA Approval Licensing 41