Common Sense for Drug Policy Blog

NOVEMBER 16, 2023

For example, one study found that 20% of patients identified as “doctor-and-pharmacy shopping” according to a commonly accepted definition using prescription-level data—a factor likely included in NarxCare’s algorithm—were in fact diagnosed with cancer, thus necessitating visits with multiple providers to adhere to complex treatment regimens.

Pharmacy

Advarra

MAY 16, 2024

sIRB Reporting Requirements Clinical trial reporting requirements can be tricky in general, and the regulations don’t always provide clear definitions or expectations (for example, noncompliance ). To address such regulatory gray areas, individual IRBs have developed their own policies and requirements.

Research

Advarra

MAY 28, 2024

“Local context” is a concept mentioned in regulatory guidance but lacking an official definition. conflict of interest, feasibility, pharmacy, etc.) However, the research community generally agrees local context covers key site-level requirements and other local considerations an sIRB must include as part of its review.

Compliance

The Pharma Data

DECEMBER 17, 2020

These follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention,” said George D. Have chronic kidney disease. Have diabetes.

Hospitals

Agency IQ

SEPTEMBER 15, 2023

Other comments from the American College of Clinical Pharmacy (ACCP) and American Association of Colleges of Pharmacy (AACP) also endorsed the actions sought in the Citizen Petition. The panel also heard from the authors of the 2007 meta-analysis that found phenylephrine to be ineffective as well as the 2015 Citizen Petition.

Science

Agency IQ

APRIL 12, 2024

Annex 2 content will also focus on RWD sources including “the use of registries, electronic health records (EHRs), hospital data, pharmacy and medical claims data or wearables,” with both hospital and wearable data considered a key opportunity in decentralized data collection methods.

Regulations

Agency IQ

AUGUST 4, 2023

a wholesaler or pharmacy) would be able to see a valid chain of custody for a product. In March, the agency finalized a long-awaited guidance document that provides specific definitions for key terms and concepts under the DSCSA – including the terms counterfeit, diverted, fraudulent transaction and unfit for distribution.

FDA

Agency IQ

AUGUST 25, 2023

However, the Farm Bill created a new definition for hemp and marijuana , allowing hemp to be removed from the CSA and facilitating an explosion in commercialization of CBD products. This meant that prior to the passage of the 2018 Farm Bill, hemp and its derivatives were considered Schedule I substances under the CSA. Earl Blumenauer (D-OR).

Regulations

The Pharma Data

OCTOBER 28, 2020

Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. TARRYTOWN, N.Y. , 28, 2020 /PRNewswire/ — . Regeneron has shared these results with the U.S.

Virus

The Pharma Data

OCTOBER 27, 2020

See definition of non-GAAP earnings, a non-GAAP financial measure, and a reconciliation of net income to non-GAAP earnings below. . 1. %. . (1).

FDA

Drug Channels

FEBRUARY 22, 2022

Pharmacies and Pharmacy Benefit Managers. Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more.

Pharmacy

The Pharma Data

JANUARY 24, 2021

Completion of the transaction is subject to customary closing conditions, including completion of due diligence, negotiation of definitive agreements and receipt of all necessary approvals. Following completion of the transaction Sairiyo will be a wholly-owned subsidiary of the Company.

FDA

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The Final Guidance clarifies that, although both applicable drugs and selected drugs must be covered under a Discount Program agreement, selected drugs are excluded from the definition of an applicable drug, so they are not subject to applicable discounts during an MFP applicability year. Non-applicable drugs (e.g., 1395w-114c(b)(4)(B)(i).

Compliance

Drug Target Review

DECEMBER 22, 2023

While pursuing a doctoral degree in regulatory science at the University of Southern California School of Pharmacy, my dissertation was titled, “Views on global harmonization of pharmacopeial standards: a survey of key stakeholders.”

Organic Chemistry

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. 1396r-8(k)(3). date of payment, date of shipment, date of invoice, etc.).

Drugs

FDA Law Blog: Biosimilars

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. What is noteworthy about this proposed definition is that it adds a new requirement that “[a] manufacturer must make data available to CMS to support its finding.”

Drugs

The Pharma Data

JANUARY 12, 2021

Definition of High-Risk Patients. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19. Have chronic kidney disease. Have diabetes.

Government

Agency IQ

JUNE 16, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

Regulations

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Biosimilars

Agency IQ

JULY 12, 2024

A 2017 European Parliament resolution called on the European Commission and the European Council “to formulate a better definition of the concept – and analyse the causes – of shortages of medicines.” On some occasions, Member States also facilitated the redistribution of available doses between hospitals and pharmacies.

Regulations

The Pharma Data

NOVEMBER 20, 2020

Definition of High-Risk Patients. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19. Have chronic kidney disease. Have diabetes. Are ?

Therapies

Agency IQ

DECEMBER 11, 2023

The data used to generate a control arm may be derived from prior clinical trial data (individual or pooled), or observational, real-world data (RWD), such as from registries, electronic health records (EHRs), and medical or pharmacy claims.

FDA

The Pharma Data

NOVEMBER 21, 2020

Definition of High-Risk Patients. Monoclonal antibodies, such as casirivimab and imdevimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19. Have chronic kidney disease. Have diabetes.

FDA

The Pharma Data

DECEMBER 29, 2020

Definition of High-Risk Patients High-risk is defined as patients who meet at least one of the following criteria: — Have a body mass index (BMI) ?35 35 — Have chronic kidney disease — Have diabetes — Have immunosuppressive disease — Are currently receiving immunosuppressive treatment — Are ?

Hospitals

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

FDA

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.

Pharmacy

The Pharma Data

MAY 14, 2021

I have a cure for hives and angioedema! It is a natural cure which means it cannot be registered as a patent thus it cannot be marketed using the regular channels (drug industry-pharmacies etc.). Let’s see a pharmacy or doctor top that! Let’s see a pharmacy or doctor top that! Let’s see a pharmacy or doctor top that!

Treatment

Agency IQ

DECEMBER 1, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. fit in this definition.

FDA

Agency IQ

AUGUST 2, 2024

Speaking of improving data in RWD sources, the HITAC annual report also points directly to the need to improve two areas of structural challenge for the FDA: consistent data standardization for laboratories , and better connectivity of pharmacy data “with the broader health IT ecosystem.”

FDA

FDA Law Blog: Biosimilars

JUNE 23, 2024

1] Under the relevant definitions in the CSA, the dispensing/delivery of controlled substances is limited to the “ultimate user” ( i.e., the patient or a member of the patient’s household). [2] 1] 21 U.S.C. § 802 (27) (The CSA’s “ultimate user” definition). [2] 2] Why is this an issue? 2] See, e.g. , id. § 3] 21 U.S.C.

Nurses

Drug & Device Law

JANUARY 4, 2024

Alabama State Board of Pharmacy , 61 F.4th Okuley’s Pharmacy & Home Medical , N.E.3d “To encourage voluntary participation in the distribution of these countermeasures, the Secretary of [HHS] invoked the [PREP Act], to provide legal immunity for the individuals and organizations who provided these countermeasures to the public.”

Vaccine

Drug & Device Law

JANUARY 30, 2024

Then she sued Moderna, the pharmacy administering the vaccine, the doctor who performed the biopsy, and the doctor’s medical practice. Manufacturing and administering a Covid-19 vaccine is the most obvious “countermeasure,” so dismissal of the claims against Moderna and the pharmacy was a foregone conclusion.

Doctors

Drug & Device Law

MAY 15, 2023

The relevant facts were quite concisely stated: In the fall of 2021, [plaintiff’s] 15-year-old [daughter] visited [defendant’s] pharmacy seeking to be vaccinated for COVID-19 without parental consent. includ[es] retail pharmacies. A court acting without “a rational and explainable basis” by definition abuses its discretion.

Vaccine

Drug & Device Law

JULY 18, 2022

Thus, as to FDCA sections using “knowing,” this statutory definition, rather than the more muscular scienter requirement Ruan imposed on prosecutorial proofs, would control. The two biggies, of course, are the definitions of “drug” and “device” found in 21 U.S.C. The same definition is employed in 21 U.S.C. 21 U.S.C. §§321(i),

Government

Drug & Device Law

MAY 2, 2022

The definitions of “goods” and “software” are also mutually exclusive. However, under the circumstances specified in the definition of “goods,” computer programs embedded in goods are part of the “goods” and are not “software.”. For UCC purposes, “software” is now considered a “general intangible,” not a “good.” Barthelemy , 643 So.2d

Production

Perficient: Drug Development

APRIL 10, 2025

Welcome to our new series on Universal Design for Pharmacies! In this segment, well explore the importance of Universal Design in Pharmacies for All Disabilities. By aligning with this principle and adopting Universal Design practices, pharmacies can make their services more inclusive and effective.

Pharmacy

Codon

APRIL 28, 2025

Eventually, he gained admission to Nagasaki Pharmacy College, which had been relocated to Isahaya after the atomic bombing destroyed its original site. After graduating, Shimomura remained at Nagasaki Pharmacy College as a teaching assistant before moving to Nagoya University as a research assistant under Yoshimasa Hirata.

DNA