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.

Pharmacy 139

Pharmacy Government Treatment Compliance 139

FDA Law Blog: Biosimilars

JUNE 23, 2024

Palmer — For more than 50 years, the Drug Enforcement Administration (DEA) has enforced the central mandate of the Controlled Substances Act (CSA) to maintain a closed chain of distribution for drugs with a potential for abuse and diversion. Gilbert & Karla L. 2] Why is this an issue? the “ultimate user”).

Nurses 98

Nurses Pharmacy Regulations Therapies 98

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. By Larry K.

Pharmacy 52

Pharmacy Drugs Regulations Compliance 52

Drug Discovery World

OCTOBER 5, 2022

DDW Editor, Reece Armstrong, sits down with Brinter CEO Tomi Kalpio to learn about the company’s approach to bioprinting and how it can be used throughout drug discovery. . RA: How can bioprinting be used to shorten drug discovery timelines? . This allows researchers to identify the best individual drugs to treat the disease. .

Pharmacogenetics 130

Pharmacogenetics Regulations Drugs Therapies 130

The Pharma Data

DECEMBER 10, 2020

Pharmaceutical Care Management Association , the Court recognized that state legislatures have important powers to regulate abuses of corporate healthcare middlemen, called Pharmacy Benefit Managers (PBMs). PBMs can exercise enormous economic leverage over pharmacies.

Regulations 52

Regulations Pharmacy Independent Pharmacies Community Pharmacies 52

FDA Law Blog: Biosimilars

MAY 16, 2024

Houck — Employee diversion of controlled substances from hospitals has been an issue since at least 1986 when I became a diversion investigator with the Drug Enforcement Administration (“DEA”). The tech’s husband distributed the drugs in the community. The nurse who allegedly stole the drugs died in March 2022.

Hospitals 59

Hospitals Nurses Compliance Pharmacy 59

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.

Regulations 40

Regulations FDA Science Production 40

Drug Discovery World

NOVEMBER 29, 2022

St George’s, University of London’s Clinical Pharmacology course saw its first graduates this year and has already been named the third best pharmacy and pharmacology course in the UK by the Guardian and is currently the highest ranked pharmacology offering. Starting with the drug. Pharmacokinetics: How the body handles drugs.

Clinical Pharmacology 130

Clinical Pharmacology Clinical Trials Drugs Drug Development 130

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Palmer , Larry K. Houck , and Kalie E.

Licensing 45

Licensing Licensing Pharmacy Regulations 45

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).

Pharmacy 52

Pharmacy Regulations Licensing Licensing 52

Drug Channels

OCTOBER 23, 2023

With regulation and policy changes, specifically surrounding the DCSCA, IRA and serialization, the loss of exclusivity wave, adoption of low-WAC products affecting GTN and the rise of alternative distribution models, there has never been a more important time for industry to unite. Drug Channels, or any of its employees.

Pharmacy 75

Pharmacy Biosimilars Production Marketing 75

Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. In early 2023, AgencyIQ conducted a landscape analysis of DCT policy in the U.S.

Regulations 40

Regulations Trials Science Clinical Trials 40

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. What is drug compounding?

FDA 40

FDA Pharmacy Production Drugs 40

FDA Law Blog: Biosimilars

JULY 31, 2023

Houck — President Barack Obama signed the Comprehensive Addiction and Recovery Act of 2016 (“CARA”) intended to reverse serious prescription drug abuse trend in the United States on July 22, 2016. Three years after that letter, DEA proposed a rule to amend its regulations consistent with CARA on December 20, 2020. By Larry K.

Long-Term Care Facilities 98

Long-Term Care Facilities Pharmacy Regulations Drugs 98

Policy Prescription

MAY 28, 2021

For the past decade, I’ve written extensively about my view that pharma-funded organizations and initiatives are responsible for misleading Americans about the safety of buying more affordable prescription drugs over the Internet for import from Canada and other countries. Here’s one example and you can be the judge.

Pharmacy 52

Pharmacy Online Pharmacies Licensing Licensing 52

Drug Discovery World

JULY 27, 2023

Alongside a number of repercussions, the most impactful to the drug discovery sector arguably relates to regulatory affairs on account of adjusting from the European Medicines Agency (EMA) to the Medicines and Healthcare products Regulatory Agency (MHRA). appeared first on Drug Discovery World (DDW).

Government 130

Government Drugs Science International 130

Drug Discovery World

FEBRUARY 22, 2023

Craig Caceci, Managing Director at Terebellum, offers guidance to pharmaceutical companies that are in the position to take their drugs to market. The challenges are even greater in the case of orphan drugs where patients need to be identified; therefore, emphasis is on diagnosis. There are many questions to ask.

Specialty Pharmacies 130

Specialty Pharmacies Drugs Marketing Clinical Trials 130

Agency IQ

AUGUST 25, 2023

Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement U.S. legislators have asked for help to reimagine how the FDA should regulate cannabidiol (CBD) following the agency’s determination that it could not make use of its existing legislative or regulatory authorities to do so.

Regulations 40

Regulations FDA Science Production 40

Fierce BioTech

JUNE 22, 2023

Accelerating Patient Identification and Improving Health Outcomes for Orphan Drug Candidates in Europe. pesurya Thu, 06/22/2023 - 12:49 Wed, 08/02/2023 - 14:00 Resource Type Webinar Duration 60 Minutes Identifying orphan drug candidates and optimizing treatment adherence can be challenging in the best of circumstances.

Specialty Pharmacies 52

Specialty Pharmacies Pharmacy Drugs Disease 52

Policy Prescription

APRIL 1, 2022

Department of Justice, according to Seeking Alpha , is investigating the sale and distribution of counterfeit drugs in the U.S. drug supply chain consisting of $250 million in counterfeit HIV drugs that were sold throughout the U.S. from licensed pharmacies to American patients.

Pharmacy 40

Pharmacy Licensing Licensing Drugs 40

FDA Law Blog: Biosimilars

JANUARY 22, 2024

Claud — The Office of Compliance (OC) at FDA’s Center for Drug Evaluation and Research (CDER) had a role in many of the major public health enforcement matters you may have read about last year. OC devoted a lot of resources to its compliance efforts directed at human drug compounding. Drug Supply Chain. By John W.M.

Compliance 59

Compliance Online Pharmacies Clinical Trials FDA 59

FDA Law Blog: Biosimilars

JUNE 2, 2023

Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program. Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers.

Drugs 59

Drugs Regulations Government Vaccine 59

Drug Discovery World

NOVEMBER 8, 2023

This efficiency expedites the identification of potential therapeutic targets, screening of drug candidates, and selecting eligible trial participants, all of which are crucial aspects of clinical trial design and execution. Global clinical regulations vary significantly, leading to disparities in medical treatment approvals.

Clinical Trials 182

Clinical Trials Trials Disease Medical Schools 182

FDA Law Blog: Biosimilars

OCTOBER 9, 2023

To help patients afford the copays and deductibles for specific medications, some drug manufacturers offer direct financial assistance, often as coupons, to subsidize the patient’s purchase of the drug at the point of sale. We previously blogged about this lawsuit last year.

Pharmacy 40

Pharmacy Regulations Drugs 40

Advarra

APRIL 30, 2024

In some countries, local regulations may indicate the sub-investigators need to sign as well. Investigational New Drug (IND) Safety Reports Attest all reports submitted by the sponsor are present, have been submitted to the IRB, and there is documentation of PI review. Pharmacy File Ensure inventory records are up to date.

Licensing 52

Licensing Licensing Pharmacy FDA 52

Perficient: Drug Development

DECEMBER 13, 2023

This article focuses on the Pharmacy Benefits Management (PBM) company, exploring the challenges such a company faces, the value it provides to its clientele, and how Perficient leverages its talent pool of business analysts, developers, architects, and process managers to provide technical solutions to address their needs.

Compliance 52

Compliance Pharmacy Clinical Trials Government 52

The Pharma Data

MAY 7, 2021

Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ). US move to loosen vaccine patents will draw drug companies to bargain ( Reuters ). International regulators and WHO call for wider public access to clinical data ( EMA ). Generic Drug Cos.

Vaccine 52

Vaccine Compounding Pharmacies Regulations Drugs 52

Drug Target Review

MARCH 19, 2024

These genes have a broad range of function including gene regulation particularly in relation to the metabolism of sugars, lipids, and mitochondrial function (among other pathways). Beyond the main retinol transport complex, what were some of the novel retinol-associated genes identified, and what biological processes are they related to?

Laboratories 105

Laboratories Bioinformatics International Research Laboratories 105

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Conditions for Coverage after January 1, 2025: Any manufacturer that wishes to have its applicable drugs covered under Medicare Part D after January 1, 2025 (“participating manufacturers”) must execute a Discount Program agreement with CMS by March 1, 2024. Non-applicable drugs (e.g.,

Compliance 105

Compliance Pharmacy Drugs Licensing 105

Common Sense for Drug Policy Blog

JANUARY 5, 2024

Melatonin, the hormone involved in the regulation of our biological clock, is released when we are exposed to daylight. It was only when its use grew further, and more evidence about its addictive potential came to light, that the United States finally passed the 1974 Drug Control Act (Rawson et al. As Crary ( 2013 , p. Chemical 24/7.

Pharmacy 52

Pharmacy Regulations Production Marketing 52

Drug Discovery World

JUNE 20, 2024

billion 1 is the estimated cost of bringing a new drug from the drawing board to pharmacy shelves today. The fusion of LLMs with clinical research processes marks a significant evolution and can help us reshape our approach to drug development and patient care. So, what are the roles of LLMs in clinical trials?

Clinical Research 147

Clinical Research Research Clinical Trials Trials 147

Drug Target Review

MARCH 6, 2024

Driven by our 3D generative algorithms, in combination with our expert drug hunters, and guided by our pipeline of models and 2D generative approaches, we designed ‘539 through iterative design and learning cycles.

Production 63

Production Pharmacokinetics Pharmacy RNA 63

Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. December also typically brings end-of-year perspectives on the agency’s accomplishments.

FDA 40

FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. There are as many PDUFA dates in November and December as we’ve seen all year.

FDA 40

FDA Science Regulations Production 40

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. AgencyIQ October 1 Nitrosamine testing due to FDA.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 17, 2024

FDA , the Alliance for Hippocratic Medicine sued the FDA, charging that the agency had violated federal law when it approved the abortion drug mifepristone and, later, amended conditions intended to assure its safe use. They were not subject to any direct regulation by the FDA related to mifepristone.

FDA 40

FDA Doctors Testimonials Regulations 40

The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. With diabetes, the body doesn’t make enough insulin to keep sugar levels regulated in the normal range.

Biosimilars 52

Biosimilars Production FDA Approval FDA 52