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.

Regulations 40

Regulations FDA Science 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

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.

FDA 40

FDA Science Regulations Production 40

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.)

Packaging 44

Packaging Compliance FDA Production 44

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

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).

Regulations 57

Regulations Pharmacy Licensing Licensing 57

Drug Channels

OCTOBER 23, 2023

Informa Connect’s Trade and Channel Strategies Hybrid Event | December 11-13, 2023 DoubleTree By Hilton | Philadelphia, PA Exclusive Offer–Be sure to use your exclusive promo code 23DC10 to save 10% off* of your registration. Copyright © 2006-2023 Pembroke Consulting, Inc. What can you expect? Drug Channels, or any of its employees.

Pharmacy 61

Pharmacy Biosimilars Production Marketing 61

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)

Long-Term Care Facilities 98

Long-Term Care Facilities Pharmacy Regulations Drugs 98

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.

Disease 111

Disease Biochemical Pharmacology FDA Approval Pharmacy 111

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

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.

Specialty Pharmacies 52

Specialty Pharmacies Pharmacy Drugs Disease 52

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.

Drugs 57

Drugs Regulations International Production 57

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.

FDA 40

FDA Science Clinical Trials Trials 40

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

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.

Pharmacy 85

Pharmacy Treatment Community Pharmacies Trials 85

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.

FDA 40

FDA Pharmacy Production Drugs 40

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.

FDA 109

FDA Production Trials Pharmacy 109

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.

Drugs 57

Drugs Regulations Government Vaccine 57

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.

Compliance 104

Compliance Drugs Pharmacy Licensing 104

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 ].

FDA 40

FDA Production Laboratories Drugs 40

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.

Therapies 52

Therapies RNA Engineering Vaccine 52

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 Clinical Trials Science 40

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.

FDA 40

FDA Science Regulations Production 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.

Therapies 115

Therapies DNA Virus Clinical Trials 115

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.

Science 40

Science Biosimilars FDA Production 40

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.

FDA 40

FDA Science Drugs Regulations 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.

FDA 52

FDA Drugs Clinical Development Disease 52

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.

Regulations 40

Regulations Production Packaging FDA 40

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.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

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.

FDA 40

FDA Laboratories Pharmacy Government 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. ].

FDA 40

FDA Trials Therapies Regulations 40

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.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Device software Select Updates for the 506J Guidance: Voluntary Notifications of Discontinuance or Interruption of Device Manufacture CDRH Draft 12/29/2023; overdue FDA must issue final guidance within one year after the close of comments for the draft guidance. New on CDRH’s guidance agenda. Priority A List.

FDA 40

FDA Science Biosimilars Clinical Trials 40

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

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. Fake DSCSA Pedigrees.

Pharmacy 40

Pharmacy Licensing Licensing Drugs 40

Drug & Device Law

MAY 19, 2023

Sorsaia , 2023 WL 3211847 (S.D.W. May 2, 2023) (“ Sorsaia ”), the plaintiff “is the only United States manufacturer of generic mifepristone,” and the defendants are West Virginia state and local prosecutors. Sorsaia , 2023 WL 3211847, at *2. Sorsaia , 2023 WL 3211847, at *4. In GenBioPro, Inc. Didn’t work.

FDA Approval 111

FDA Approval Pharmacy FDA Production 111

Drug & Device Law

MAY 26, 2023

Ct. — , 2023 WL 3356528 (U.S. May 11, 2023) (“NPP”), evidences each of those old saws. We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. A state cannot regulate commerce occurring wholly outside its borders. 21–468, — S.

Regulations 59

Regulations Production FDA FDA Approval 59