The Pharma Data

JANUARY 18, 2021

In yesterday’s online edition of Forbes magazine, Ahmad Doroudian, CEO of BetterLife, further emphasized the significant barriers that current regulations impose on development of the current generation of psychedelics and LSD based compounds and advantages of non-controlled second generation psychedelics such as TD-0148A.

Pharmacy 40

Pharmacy Regulations Treatment Licensing 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. The FDA will follow these procedures for both agency-initiated operations (e.g.,

Science 40

Science FDA Clinical Trials Clinical Pharmacology 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

Policy Prescription

OCTOBER 22, 2024

Harvard doctors and public health experts recommend using the website PharmacyChecker.com to find international online pharmacies to order more affordable prescription drugs for personal importation when domestic savings strategies fail. They offer this advice in a new article in the Journal of the American Medical Association.

Online Pharmacies 113

Online Pharmacies Pharmacy Drugs FDA Approval 113

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. Most recently, Regulation (EU) 2022/123 requires the EMA to monitor shortages that could lead to crisis situations.

Regulations 40

Regulations Production Packaging FDA 40

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

Policy Prescription

JANUARY 31, 2022

state boards of pharmacy to properly regulate pharmacies that irresponsibly and too often illegally profited from opioid drug sales to patients. So, where was the West Virginia Board of Pharmacy? After 2012, the West Virginia Board of Pharmacy received over 7200 suspicious drug order reports.

Pharmacy 52

Pharmacy Regulations Doctors Drugs 52

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

Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

Science 40

Science FDA Production Packaging 40

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.

Therapies 135

Therapies Virus DNA Clinical Trials 135

Agency IQ

DECEMBER 11, 2023

Previously, burdensome side effects may have been written off as a necessary part of treatment and benefits measured in additional weeks or months of survival time; today, though, patients, clinicians, and regulators expect more. For a more complete discussion of endpoints in oncology clinical trials, see this recent AgencyIQ article.

FDA 40

FDA Science Clinical Trials Trials 40

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. Earlier this month, FDA scientists from CDER’s Office of Therapeutic Biologics and Biosimilars and the Division of Biometrics VIII published an article in Plos One.

Science 40

Science Biosimilars FDA Production 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

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. Read DNA Sequencing & Synthesis *Quantitative analysis of tRNA abundance and modifications by nanopore RNA sequencing.

Therapies 52

Therapies RNA Engineering Vaccine 52

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.

FDA 40

FDA Science Regulations Production 40

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 40

FDA Science Biosimilars Clinical Trials 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

Agency IQ

JUNE 17, 2024

Under Article III of the Constitution , a party must have “standing” to challenge a rule or law. They were not subject to any direct regulation by the FDA related to mifepristone. Plaintiffs lack Article III standing to challenge FDA’s actions regarding the regulation of mifepristone,” the court wrote.

FDA 40

FDA Doctors Testimonials Regulations 40

Drug Patent Watch

JANUARY 29, 2025

Manufacturers must navigate a complex web of laws and regulations, including those related to patent protection, intellectual property, and safety standards. Manufacturers must establish relationships with wholesalers, pharmacies, and other stakeholders to get their products to market. Read the full article here: [link]

Production 64

Production Compliance Drugs Pharmacy 64

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 40

FDA Laboratories Pharmacy Government 40

FDA Law Blog: Biosimilars

APRIL 22, 2025

The stakes are high when a DEA-registered practitioner, pharmacy, distributor, manufacturer, or other registrant receives an Order to Show Cause (or OSC) from DEA. If you decide to request a hearing, DEAs revised hearing regulations require that you simultaneously file an Answer to the Order to Show Cause.

Testimonials 52

Testimonials Government Pharmacy Regulations 52

Drug Target Review

MARCH 13, 2025

The journey from distrust to collaboration among industry, academia and regulators will expedite integration, minimise clinical failures and enhance economic sustainability. This article, along with other insightful analyses, will be featured in our upcoming report, Beyond the Lab – Artificial Intelligence, launching on 21st March 2025.

Drug Development 59

Drug Development Science Clinical Trials FDA 59

Advarra

DECEMBER 14, 2022

Pharmacy manual. These assessments are supported by Medicare-approved guidelines and/or journal articles. The trial is in compliance with Federal regulations relating to the protection of human subjects. Identifies what items/services sponsor reimburses, and therefore not eligible for Medicare coverage. Optional Documents.

Clinical Trials 52

Clinical Trials Trials Compliance FDA Approval 52

Drug & Device Law

DECEMBER 29, 2023

2023) (First Amendment bars state-law misrepresentation claims over “truth” of published scientific article) ( here ); National Association of Wheat Growers v. Alcozar didn’t buy it, since the particular regulations did not even apply to the clinics and health care providers that plaintiffs were targeting. 4th 315 (6th Cir.

Testimonials 105

Testimonials Drugs FDA Vaccine 105

Drug & Device Law

OCTOBER 25, 2023

We don’t remember what the legislation was about, but we do remember the consumer affairs guy regaling us with stories about how easy it was for state investigators to find all sorts of violations of consumer fraud regulations. Central Admixture Pharmacy Services, Inc. , That isn’t necessarily the result of anything nefarious.

FDA 59

FDA Packaging Production Regulations 59

Drug & Device Law

MAY 19, 2023

Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom Frontier” – which will soon be published in the Food & Drug Law Journal. A draft of this article is now available on SSRN.

FDA Approval 111

FDA Approval Pharmacy FDA Production 111

Drug & Device Law

JULY 18, 2022

II) knowingly or intentionally falsely designated in an authorized electronic data interchange system as a product that is regulated by the Secretary. Section 331(ccc)(2), prohibiting “the intentional falsification of a prescription” for a pharmacy compounded drug. Emphasis added). 321(bb). See , e.g. , 21 C.F.R.

Government 59

Government FDA Pharmacy Production 59