Drug Channels

MARCH 14, 2022

Asembia’s Specialty Pharmacy Summit 2022. Asembia's Specialty Pharmacy Summit 2022 is back! This is a must-attend event for anyone connected to specialty pharmacy. Scott Gottlieb, former FDA commissioner and author of Controlled Spread , will deliver the keynote address. May 2 – 5, 2022 | Las Vegas www.asembiasummit.com.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Houck — Separate decisions by federal district courts in Texas and Puerto Rico in the past two months provide cautionary tales for every pharmacy and wholesale distributor dispensing or distributing controlled substances. This post examines the Zarzamora pharmacy and prescribing red flags decision. d/b/a CVS/Pharmacy, Nos.

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SCIENMAG: Medicine & Health

OCTOBER 31, 2023

— A new drug developed by professors from the School of Pharmacy and Pharmaceutical Sciences at Binghamton University has received Food and Drug Administration (FDA) approval for the treatment of patients with Duchenne muscular dystrophy (DMD), a common genetic disease that mostly affects young boys. BINGHAMTON, N.Y.

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Drug Channels

NOVEMBER 22, 2021

In this issue: The State of Specialty Pharmacy 2021 How health plans profit—and patients lose—from insulin A fantastic new analysis of the gross-to-net bubble CVS acknowledges how its PBM profits from 340B Reconsidering Amazon Plus, the FDA preps you for Thursday with a regulatory soup review.

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FDA Law Blog: Biosimilars

MAY 30, 2024

Initially, drug manufacturers were required to offer these discounts only to the in-house pharmacies of covered entities. In 2010, the Health Resources and Services Administration (HRSA) authorized covered entities to contract with an unlimited number of retail pharmacies to fill prescriptions for their patients.

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FDA Law Blog: Biosimilars

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

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FDA Law Blog: Biosimilars

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103). Decision at 8-9.

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FDA Law Blog: Biosimilars

AUGUST 21, 2023

Attorney’s Office for the Western District of Texas announced that People’s Rx, a local chain operating five retail pharmacies and a compounding laboratory in the Austin area, agreed to pay $200,000 to settle allegations that it violated the Controlled Substances Act (“CSA”). 16, 2023 ( DOJ Press Release ). 2, 2020 ( DOJ Press Release ).

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The Pharma Data

JULY 29, 2021

. “This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said Acting FDA Commissioner Janet Woodcock, M.D. Biosimilars marketed in the U.S.

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Conversations in Drug Development Trends

FEBRUARY 21, 2024

While traditionally conducted during Phase 2 or later, the FDA has recently been requesting data sooner in the development process, making it critical to implement proactive AME studies to lay the groundwork for advanced phases of your clinical program. To accomplish this, we pay careful attention to both dosing and sample collection.

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Alta Sciences

DECEMBER 14, 2023

A Closer Look At Our On-Site Compounding Pharmacies shajjar Thu, 12/14/2023 - 21:30 HTML Altasciences' dedicated pharmacists bring a wealth of expertise in controlled substances and complex compounding, ensuring maximum precision and safety standards. Electronic security access to the pharmacy and video monitoring. -

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FDA Law Blog: Biosimilars

MARCH 4, 2024

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. By Véronique Li, Senior Medical Device Regulation Expert & Deborah L.

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Policy Prescription

JANUARY 11, 2024

LegitScript argued that PharmacyChecker does not have antitrust standing because its business, providing information on the Internet that Americans use to find vetted international online pharmacies and compare their prices, is unlawful. Judge Simon disagreed, writing “PharmacyChecker.com’s business is legal.” ” (Emphasis added).

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The Pharma Data

DECEMBER 11, 2020

With our nationwide store footprint, extensive vaccine experience and pharmacy team members embedded in communities across the country, we are prepared to expand access to the general population through our more than 9,000 stores once COVID-19 vaccines become available more broadly in 2021. About Walgreens.

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Drug Patent Watch

DECEMBER 10, 2024

Food and Drug Administration (FDA) emphasizes the use of quantitative methods and modeling (QMM) to modernize generic drug development. This involves understanding the legal and ethical standards set by regulatory agencies such as the FDA and the European Medicines Agency (EMA). Retrieved from [link] East Street Pharmacy.

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Agency IQ

MARCH 25, 2024

In proposed rule, FDA offers up a (surprisingly sparse) list of drugs that present demonstrable compounding difficulties FDA yesterday released a long-awaited proposed rule on a list of drug products that present demonstrable difficulties for compounding. The result was the addition of Section 503A to the FD&C Act.

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Policy Prescription

OCTOBER 3, 2023

Salant’s paper supports personal drug importation and legalizing the importation of prescription drugs for commercial use so that wholesale pharmacies, including companies like Amazon and Costco, could tap into the parallel importation markets of other countries. pharmacies and personal imports from India can be safe as well.

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Drug Channels

FEBRUARY 6, 2023

Access USA will unite PAP – Patient Assistance & Access Programs, Hub and Specialty Pharmacy Models East and Rare Disease Innovation & Partnership Summit, three industry-leading access conferences under one roof for one week of collaborative discussions and opportunities to expand your network and establish powerful partnerships.

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Drug Target Review

MARCH 12, 2024

Scientists from the Skaggs School of Pharmacy and Pharmaceutical Sciences at the University of California San Diego have discovered thousands of bile acids. The study’s findings offer new insights into the biochemical language microbes use to influence distant organ systems, which could revolutionise the way researchers approach disease.

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DrugBank

SEPTEMBER 26, 2024

Food and Drug Administration (FDA) have been instrumental in shaping global regulatory frameworks for biosimilars. United States  In contrast, the FDA employs a stepwise approach, focusing on demonstrating no clinically meaningful differences from the reference product through a structured development program.

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Advarra

APRIL 30, 2024

If documentation is incomplete, sites run the risk of regulatory inspection findings such as a Form FDA 483. Form FDA 1572 The Form FDA 1572 is unique to U.S.-based do not use Form FDA 1572s, so sponsors may need to request these sites sign a different document. Pharmacy File Ensure inventory records are up to date.

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The Pharma Data

JANUARY 13, 2021

Mr. Barrow has over a decade of experience leading drug development programs aimed at identifying and testing novel treatments in a wide range of disease conditions under FDA and EMA. . NEW YORK , Jan. MindMed Co-CEO J.R.

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Agency IQ

JANUARY 4, 2024

Now, the FDA has released guidance laying out the tests and regulatory submissions needed for the reformulation of products containing these ingredients. To help control impurities, the FDA requires all starting materials used in drug manufacturing and final pharmaceutical products to be evaluated for “identity, strength, quality and purity.”

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Agency IQ

AUGUST 16, 2024

The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways On August 9, Lykos Therapeutics received a Complete Response Letter (CRL) from FDA stating the agency will not currently approve its application for midomafetamine (MDMA) to treat post-traumatic stress disorder.

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Policy Prescription

MARCH 11, 2022

It’s important because this case was wrongly used as a pretext to oppose safe personal drug importation and international online pharmacies, which help Americans afford prescription drugs. It seems that the appellant was also told that MHRA would notify the FDA of the situation. Clearly it did so. supply chain.

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FDA Law Blog: Biosimilars

JANUARY 22, 2024

OC and CDER continue to use a carrot-and-stick approach with compounders, noting both the creation of the Compounding Quality Center of Excellence and its collaboration with the industry, but also the eleven warning letters FDA sent to drug compounders last year. Drug Supply Chain. Clinical Trials.

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Policy Prescription

MAY 28, 2021

The NeedyMeds host then asks Mr.Safdar: “Are there any pharmacies in Canada that are safe to purchase brand name drugs from…? and licensed by your state board of pharmacy.” They are wondering if there’s a way to determine the quality of those mail-order pharmacies. state-licensed board of pharmacy licensed pharmacy.”.

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Advarra

MARCH 6, 2025

Food and Drug Administrations (FDA) regulations on good clinical practice, which are based on ethical standards outlined in frameworks such as the Belmont Report and the Declaration of Helsinki. Advarra ensures that clinical trials comply with the U.S.

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FDA Law Blog: Biosimilars

JULY 31, 2023

Pharmacists could partially fill a schedule II prescription if the pharmacy is unable to supply the full quantity of a written or emergency oral prescription. In addition, a pharmacist could partially fill a schedule II prescription issued to patients in a Long Term Care Facility or who have a terminal medical illness diagnosis.

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FDA Law Blog: Biosimilars

AUGUST 9, 2023

Houck — If a patient presents a paper prescription for a controlled substance to a pharmacy and the pharmacy cannot fill it, the patient can take that prescription to another pharmacy. Instead, the patient must request that the prescriber send a new prescription to a different pharmacy. 48365, 48369 (July 27, 2023).

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The Pharma Data

DECEMBER 17, 2020

Doctor Johnson has had an inspiring career that encompasses several aspects of the pharmacy industry. By working with the most extensive and only FDA aligned lab in America, Doctor Johnson is able to provide this amazing gene test that has been proven to save lives and improve outcomes to anyone, anywhere in America.

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Policy Prescription

APRIL 1, 2022

from licensed pharmacies to American patients. This epic counterfeit drug debacle had nothing to do with the personal importation of less expensive prescription drugs or foreign online pharmacies. pharmacies and wholesalers allegedly flouting the rules. Safe Chain Pharmacy Solutions. The complaint states: .

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FDA Law Blog: Biosimilars

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). By Kalie E. Richardson & Karla L. See 21 U.S.C. Section II at 2.

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Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Watch the video. Listen here.

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Alta Sciences

JULY 25, 2024

TOP MANUFACTURING AND ANALYTICAL SCIENTIFIC RESOURCES Podcast: Successful Manufacturing of Clinical Trial Supply Join our formulation and pharmacy experts as they share insider secrets for overcoming clinical trial challenges and resolving issues that could impact your drug development program's timeline. Watch the poster presentation.

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FDA Law Blog: Biosimilars

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. Coconut Grove Pharmacy; Decision and Order, 89 Fed. Gulf Med Pharmacy; Decision and Order, 86 Fed. 72,694, 72,703 (Dec.

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The Pharma Data

SEPTEMBER 21, 2020

This follows a similar recall of thyroid medications that was issued by the FDA in recent weeks. Acella Pharmaceuticals is recalling two types of its thyroid medication as the drugs may be too weak to properly treat those who take them. .

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