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 Pharmacy 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

FDA Law Blog: Biosimilars

OCTOBER 9, 2023

This financial assistance directs the pharmacy to bill all or part of the patient’s copayment obligations to the manufacturer instead of the patient. The Court specifically concluded that the rule “rests on two contradictory interpretations of the statute” and “conflict[s] with the regulatory definition.”

Pharmacy 40

Pharmacy Regulations Drugs 40

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

Agency IQ

JULY 12, 2024

A 2017 European Parliament resolution called on the European Commission and the European Council “to formulate a better definition of the concept – and analyse the causes – of shortages of medicines.” Following this regulation, the EMA now coordinates shortage prevention, management and communication efforts among Member States.

Regulations 40

Regulations Packaging Production FDA 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

Advarra

MAY 16, 2024

sIRB Reporting Requirements Clinical trial reporting requirements can be tricky in general, and the regulations don’t always provide clear definitions or expectations (for example, noncompliance ). To address such regulatory gray areas, individual IRBs have developed their own policies and requirements.

Compliance 52

Compliance Research Trials Regulations 52

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

DECEMBER 3, 2023

The Final Guidance clarifies that, although both applicable drugs and selected drugs must be covered under a Discount Program agreement, selected drugs are excluded from the definition of an applicable drug, so they are not subject to applicable discounts during an MFP applicability year. Non-applicable drugs (e.g., 1395w-114c(b)(4)(B)(i).

Compliance 105

Compliance Pharmacy Drugs Licensing 105

The Pharma Data

MAY 13, 2021

I Have A Doctorate In Pharmacy, But Everything I Learned About Pain Relief In Pharmacy School Is Dead Wrong! Which is how I got into pharmacy — after all, what better way to spend your life than by removing illness from the world. . … And then got my Doctor of Pharmacy (Pharm.

Pharmacy 52

Pharmacy Doctors Production Therapies 52

Advarra

MAY 28, 2024

“Local context” is a concept mentioned in regulatory guidance but lacking an official definition. conflict of interest, feasibility, pharmacy, etc.) Researchers and institutions must ensure the sIRB is aware of local requirements, state laws and statutes, and other regulations governing regulatory compliance.

Compliance 52

Compliance Research Government Regulations 52

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

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. At the same time, big data presents exciting opportunities. For example, improved methods in data collection (e.g.,

FDA 40

FDA Science Clinical Trials Trials 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 Production 40

FDA Law Blog: Biosimilars

JUNE 23, 2024

The CSA and regulations promulgated by DEA are intended to reduce the potential for diversion and abuse and ensure that controlled substances are dispensed and delivered to patients for a legitimate medical purpose. 2] Why is this an issue? the “ultimate user”).

Nurses 98

Nurses Pharmacy Regulations Therapies 98

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. percent on a dry weight basis. ”

Regulations 40

Regulations FDA Science Production 40

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. Thus, as to FDCA sections using “knowing,” this statutory definition, rather than the more muscular scienter requirement Ruan imposed on prosecutorial proofs, would control.

Government 59

Government FDA Pharmacy Production 59

Drug & Device Law

JANUARY 4, 2024

Alabama State Board of Pharmacy , 61 F.4th Okuley’s Pharmacy & Home Medical , N.E.3d 341 (2001), and the exclusivity Buckman recognized of FDA authority over approval of the products it regulates also provide grounds for implied conflict preemption those the Complaint’s allegations. 4th 902, 905 (11th Cir. Leonard , 61 F.4th

Vaccine 59

Vaccine FDA FDA Approval Pharmacy 59