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”). Regulated sellers must limit daily sales of SCLPs to 3.6

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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.

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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.

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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

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price. See 42 U.S.C.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

With apologies to Curtis Mayfield) By the close of the public comment period for the Drug Enforcement Administration’s (“DEA’s”) proposal to reschedule marijuana two weeks ago, the agency had received over 43,500 comments. Some states have authorities that regulate marijuana exclusively. 53,767 (Aug.

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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.

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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.

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National Institute on Drug Abuse: Nora's Blog

JULY 22, 2024

Volkow, National Institute on Drug Abuse Image ©Getty images/ seb_ra Over the past several years, the increasing prevalence of fentanyl in the drug supply has created an unprecedented overdose death rate and other devastating consequences. in that period.

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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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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.

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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.

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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. By Larry K.

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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.

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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.

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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.,

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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?

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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.

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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. What is drug compounding?

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Drug Target Review

DECEMBER 22, 2023

The regulatory science project I pursued for my first master’s degree titled, “21st Century Pharmaceutical Excipients: Consequences of a Global Supply Chain and Lack of Excipient Regulations” aimed to draw attention to the risks created by the lack of sufficient oversight of the pharmaceutical excipient supply chain.

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The Pharma Data

AUGUST 17, 2020

The UK government is imposing stricter regulations on the sale of laxatives, to help prevent their misuse. The drugs, designed to treat constipation, will be sold in smaller packs that carry warnings about never using laxatives for weight control. People will need to be 18 or older to buy them from pharmacies and supermarkets.

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Codon

FEBRUARY 13, 2024

doi: 10.2210/rcsb_pdb/goodsell-gallery-048 The Virus that Cures It’s been over 25 years since the science magazine Discover first ran an extraordinary article about how a long-forgotten medical treatment, used in the former Soviet country of Georgia, could save us from the growing threat of untreatable, drug-resistant infections.

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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.

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The Pharma Data

DECEMBER 30, 2020

Regulators said that the first dose of the vaccine had 70% effectiveness in protecting against COVID-19 in the period between the first dose taking effect and a second shot. Food and Drug Administration said. Some people in clinical trials of the Oxford-AstraZeneca vaccine were given the two doses several months apart. Source link.

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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.

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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.

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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.

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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.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. Since the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA) in 2012, manufacturers have been required to notify FDA of product changes affecting certain finished drugs and biological products.

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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.

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FDA Law Blog: Biosimilars

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below.

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The Pharma Data

MAY 27, 2022

Food and Drug Administration is providing an update on steps it has taken that will lead to millions of bottles of specialized medical infant formula to help address immediate needs for infants with certain allergies or critical health conditions. Today, the U.S. We continue to work closely with our U.S. as quickly as possible.

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The Pharma Data

MAY 13, 2021

Indian states turn to anti-parasitic drug to fight COVID-19 against WHO advice ( Reuters ). Japan vaccine chief blames drug approval system for slow inoculation drive ( Reuters ). Vaccine waiver talks can make drug firms the heroes, US trade chief says ( Reuters ) ( Law360 ). Medtech.

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The Pharma Data

AUGUST 8, 2020

What sets the two drugs apart could lie in the overall survival data, the gold standard when evaluating cancer drugs. Lilly earned Chinese rights to Tyvyt through a pact the two signed in 2015, and the drug was first approved in December 2018 in third-line classic Hodgkin lymphoma. months for the Keytruda combo, versus 4.9

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Drug Channels

SEPTEMBER 29, 2020

Exclusive Offer for Drug Channels Readers – View the complete agenda and register today – Be sure to use your exclusive promo code USAVE3 to save $300 *. As managing copay programs continues to be significantly more complex, it is imperative to stay on top of current trends, emerging regulations and future legislation.

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Advarra

SEPTEMBER 7, 2023

Together, these three principles form the foundation upon which HRPPs were established and provide the basis for laws, regulations, guidelines, and policies governing human subjects research. They must ensure research is conducted in compliance with the protocol and applicable policies and regulations.

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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.

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