Packaging, Pharmacy and Regulations - Drug Discovery Digest

What is Special about September 24, 2023 for the UDI System?

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. Devices can have both a UPC code and a UDI on their label and package.

Packaging

Packaging Compliance FDA Production

Analysis Life Sciences Thank You Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement

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

Regulations FDA Science Production

Analysis Life Sciences Thank You After 13-year review, FDA finalizes ‘clear, conspicuous and neutral’ drug advertising rule

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

FDA Science Drugs Regulations

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

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

Regulations FDA Science Production

Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines

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. active pharmaceutical ingredient, fill/finish, packaging/labeling). See AgencyIQ’s analysis of EMA’s milestones.]

Regulations

Regulations Production Packaging FDA

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

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

Science FDA Production Packaging

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

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

FDA Science Regulations Production

CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

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

Drugs Regulations Production International

Scaling Phage Therapy

Codon

FEBRUARY 13, 2024

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. Phage therapies are sold at a pharmacy in Georgia.

Therapies

Therapies Virus DNA Clinical Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

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

FDA Science Regulations Production

Which Arthritis Painkiller Works the Fastest?

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

Pharmacy Doctors Production Therapies

Health Highlights: Dec. 30, 2020

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. Consumers should not use any of this prescription oral rinse, which was distributed to dental offices and pharmacies nationwide, CBS News said. © 2020 HealthDay.

Vaccine

Vaccine Pharmacy Clinical Trials Packaging

A Texas Mess

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. 247d-6d(b)(8). “To

Vaccine

Vaccine FDA FDA Approval Production

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

DECEMBER 29, 2023

Indeed, even the weird alternatives the plaintiff advocated, such as “point of sale” signs and DTC advertising (assuming these were Prop 65 remedies at all), were still FDA-regulated labeling. Alcozar didn’t buy it, since the particular regulations did not even apply to the clinics and health care providers that plaintiffs were targeting.

Testimonials

Testimonials Drugs FDA Vaccine

N.D. Cal. Sees No Standing or Merit in Eye Cosmetic Claims

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. Weigh any packaged meat at a grocery store, and there’s a decent chance the weight will be wrong.

FDA

FDA Packaging Production Regulations

Drug Discovery Digest

What is Special about September 24, 2023 for the UDI System?

Analysis Life Sciences Thank You Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement

Trending Sources

Analysis Life Sciences Thank You After 13-year review, FDA finalizes ‘clear, conspicuous and neutral’ drug advertising rule

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Article EMA Thank You New EC report dives deep to better understand shortages of critical medicines

Analysis Life Sciences Thank You The cost of artificially short expiration dates: Worsened shortages, higher costs and more waste

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

Scaling Phage Therapy

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Which Arthritis Painkiller Works the Fastest?

Health Highlights: Dec. 30, 2020

A Texas Mess

The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

N.D. Cal. Sees No Standing or Merit in Eye Cosmetic Claims

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