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

JULY 31, 2023

Three years after that letter, DEA proposed a rule to amend its regulations consistent with CARA on December 20, 2020. Now, in July 2023, DEA has finally issued its final rule amending its regulations for partial filling of prescriptions for schedule II substances. 46,983 (July 21, 2023). 78,282 (Dec. b)(5)(i)). (2)

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Long-Term Care Facilities Pharmacy Regulations Drugs 98

Drug Discovery World

NOVEMBER 8, 2023

Global clinical regulations vary significantly, leading to disparities in medical treatment approvals. DDW Volume 24 – Issue 4, Fall 2023 References 2022 Heart Disease & Stroke Statistical Update Fact Sheet, American Heart Association. NY Post 20 March 2023. Psychology Today 25 January 2023. Chem Sci 2023;14:1443-145.

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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.

Pharmacy 52

Pharmacy Drugs Regulations Compliance 52

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. Bile acids are crucial signalling molecules that aid the regulation of the immune system and have essential metabolic functions, like controlling lipid and glucose metabolism.

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Disease Biochemical Pharmacology FDA Approval Pharmacy 111

National Institute on Drug Abuse: Nora's Blog

JULY 22, 2024

Under this strategy, in 2023, HHS eliminated the X-waiver requirement for buprenorphine. Recent trials of models of methadone dispensing in pharmacies and models of care based in other settings than OTPs have not supported concerns that making methadone more widely available will lead to harms like overdose.

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Pharmacy Community Pharmacies Treatment Trials 98

Fierce BioTech

JUNE 22, 2023

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. Developing a patient support program blueprint that can be adapted to fit different European national regulations.

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Specialty Pharmacies Pharmacy Drugs Disease 52

The Pharma Data

OCTOBER 27, 2021

GSK Consumer Healthcare today unveils a three-year programme to support the pharmacy profession with additional practical resources, mental health provisions and proposed policy changes as part of its new report Standing with Pharmacists in the Age of Self-Care.

Pharmacy 52

Pharmacy International Pharmaceuticals Regulations 52

Drug Discovery World

DECEMBER 18, 2023

Digital biomarkers promise to transform preventive medicine and clinical trials, but also raise issues of security, regulation and potential disparities in access. The integration of technology in healthcare not only promises advancements but also raises concerns about security, regulation and potential disparities in access.

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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 ). RWD can be collected from a wide range of sources, such as electronic health records, registries, administrative claims, pharmacy data, and feedback from wearables and mobile technology.

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Drug Discovery World

APRIL 14, 2023

Pettit Nassi and Perlmutter will be honoured during the AACR Annual Meeting 2023 Opening Ceremony on Sunday April 16 at 8am ET. The team will be honoured during the AACR Annual Meeting 2023 Opening Ceremony on Sunday April 16 at 8am ET. Delattre’s award lecture will be held on Tuesday April 18 at 5pm ET.

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Clinical Trials Research Science Clinical Research 130

Drug Discovery World

FEBRUARY 22, 2023

Regulators, payers and other stakeholders (not to mention you and your team) will want to see that you have an infrastructure in place and are ready to go. DDW Volume 24 – Issue 1, Winter 2022/2023 About the author Craig Caceci, Managing Director, Terebellum.

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Agency IQ

SEPTEMBER 15, 2023

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. On March 21, 2023, the CHPA issued a press statement applauding the FDA’s actions.

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Science FDA Clinical Trials Pharmacy 40

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Read AgencyIQ analysis here for a detailed discussion of these issues. ].

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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. 11, 2023 ( DOJ Press Release ). 11, 2023 ( DOJ Press Release ). 6, 2023 ( DOJ Press Release ).

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Pharmacy Government Treatment Compliance 139

Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. She also does not believe that the problems with Europe’s medicines can be solved with regulation. appeared first on Drug Discovery World (DDW).

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Clinical Trials Biosimilars Pharma Companies Production 130

Agency IQ

JANUARY 4, 2024

For regulators, there are two primary concerns associated with impurities – that they may cause a drug substance to degrade (thereby reducing its efficacy or safety) and that the impurities (or their effects on the drug substance) may be harmful to patients. FDA-2023-D-5408 Read AgencyIQ’s analysis of the ICH guideline here ].

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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.

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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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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 latest update, announced this week, is known as the Spring 2023 Unified Agenda.

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Regulations FDA Science 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.

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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.

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FDA Law Blog: Biosimilars

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. § 812 (b)(1).

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Regulations Pharmacy Licensing Licensing 59

FDA Law Blog: Biosimilars

MARCH 27, 2023

Baumhardt, Senior Medical Device Regulation Expert — The Unique Device Identification (UDI) System final rule requires all medical devices to bear a unique numeric or alphanumeric code in easily readable plain-text and machine-readable form. So, what is special about September 24, 2023? By Philip Won & Lisa M. Emphasis added.)

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Packaging Compliance FDA Pharmacy 45

Agency IQ

OCTOBER 20, 2023

” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. A few months later in January 2023, the agency released a “ BsUFA Research Roadmap ,” which further outlined the specific action items under the pilot.

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Science Biosimilars FDA Production 40

Drug Discovery World

JULY 27, 2023

1 Post-exit With the above-mentioned in mind, let’s take a look at what the UK government has done in order to keep the sector afloat from a regulatory perspective. In March 2023, the UK’s HM Treasury awarded £10 million to the MHRA to help bring innovative new medicines and medical technologies to UK patients more quickly 2.

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Government Drugs Science International 130

Agency IQ

NOVEMBER 27, 2023

The regulations also provided clarification regarding what does not constitute a “true statement,” including false or misleading information, failure to reveal important facts, and/or the lack of a fair balance between side effects/contraindications and effectiveness.

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FDA Science Drugs Regulations 40

Agency IQ

JULY 12, 2024

Regulation (EU) 2022/123 , which called for a “reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices,” expanded EMA’s mandate to monitor and mitigate shortages at the E.U. One of the things required by the Commissioner in October 2023 was an analysis of the E.U.

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Regulations Packaging Production FDA 40

The Pharma Data

JANUARY 24, 2021

billion during 2019-2023 (Technavio 2019). 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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FDA Drugs Clinical Development Pharmaceutical Companies 52

Agency IQ

MARCH 25, 2024

This proposed rule has been in the works for over 20 years, during which time the regulation of drug compounding has gone through many changes. An “outsourcing facility” per Section 503B is a registered location that engages in the compounding of sterile drugs but is not required to be a licensed pharmacy.

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FDA Pharmacy Production Drugs 40

Agency IQ

DECEMBER 11, 2023

The FDA and oncology: 2023 year in review As we round the corner into the last few weeks of 2023, AgencyIQ has taken a look back at a very busy year for the FDA’s oncology staff, and for sponsors. As more data have been collected on products previously approved, regulators have started to look back at them with a more critical gaze.

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Agency IQ

AUGUST 2, 2024

ASTP/ONC will lead HHS’ work under the 2023 Executive Order (EO) from President Biden on “Safe, Secure, and Trustworthy” development and use of AI. [ Gaps in pharmacy data connectivity (the subject of a separate HITAC report from November 2023 ) are also expanding. See AgencyIQ’s analysis of that EO here.

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FDA Laboratories Pharmacy Government 40

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Below, we provide a high-level summary of the Final Guidance, focusing on the legal and regulatory updates from the May 2023 draft guidance. before such manufacturer signs a Discount Program agreement) and non-binding of their phase-in eligibility if they provide CMS all ownership information by December 8, 2023.

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Compliance Pharmacy Drugs Licensing 105

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. It is not our purpose to describe all of the nearly 20 changes proposed in this regulation, but the most noteworthy are described below, roughly in order of importance.

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Drugs Regulations Government Vaccine 59

Agency IQ

FEBRUARY 12, 2024

Under the FDA’s Good Guidance Practices regulation at 21 CFR 10.115 , the agency is required to annually publish “a list of possible topics for future guidance document development or revision during the next year.” Our review found that CDER is planning several notable new guidances, including one on artificial intelligence.

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Biosimilars Science Clinical Pharmacology FDA 40

Codon

FEBRUARY 13, 2024

Fast forward to 2023. Regulators traditionally want to see a single, stable, well-characterized drug before giving the green light for it to be tested in a clinical trial, not dozens of different viruses; let alone ones that are best found in unappealing places like sewage , hospital waste, or bird poop.

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Therapies Virus DNA Clinical Trials 118

Codon

APRIL 9, 2023

Read Probe-based bacterial single-cell RNA sequencing predicts toxin regulation. A programmable and red light-regulated CRISPR-dCas9 system for the activation of endogenous genes in Saccharomyces cerevisiae. The global VC market shrank by more than half in the first quarter of 2023 compared to the same time last year.

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