Biosimilars, Pharmacy, Regulations and Treatment

FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

The Pharma Data

JULY 29, 2021

Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus. Semglee (insulin glargine-yfgn) is the first interchangeable biosimilar product approved in the U.S.

Biosimilars

Biosimilars Production FDA Approval FDA

Pharmacists in Florida (and Elsewhere): Waive Prescribing Red Flags at Your Peril

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

Pharmacy Drugs Regulations Compliance

Electronic Controlled Substance RXs: Signed, Sealed, Delivered But Can’t be Filled

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

Pharmacy Regulations Licensing Licensing

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

UMNs have been defined in the context of the draft as diseases where there’s a lack of good treatments, and which have a high burden 3. What of the increased possibilities for ‘replacement pharmacy compounding’ for weekly hospital supplies, and for routine manufacturing of cell and gene therapies without a marketing authorisation?

Clinical Trials

Clinical Trials Biosimilars Pharma Companies Production

Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms

FDA Law Blog: Biosimilars

JUNE 16, 2023

Prohibition on Excessive Price Increases The law prohibits manufacturers from imposing or causing to be imposed an “excessive price increase,” whether directly or through a wholesale distributor, pharmacy, or similar intermediary, on the sale of any generic or off-patent drug sold or dispensed to any consumer in the state.

Drugs

Drugs Biosimilars Production Treatment

Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

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. This post examines the Zarzamora pharmacy and prescribing red flags decision. d/b/a CVS/Pharmacy, Nos.

Pharmacy

Pharmacy Government Treatment Compliance

Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

FDA Law Blog: Biosimilars

MARCH 4, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Deborah L. By actively updating the information related to shortages, FDA intends to allow the public and prescribers to develop alternative treatment plans before learning a prescription cannot be filled at the pharmacy when there is a supply issue.

FDA

FDA Production Marketing Pharmacy

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

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

FDA Science Regulations Production

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

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

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

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.

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

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

Drugs Regulations Government Vaccine

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area.

FDA

FDA Science Biosimilars Production

DEA’s Expected Guidance: It Should Reduce Current “Pain” at the (Intrathecal Pain) Pump Dispensing Process and Improve Therapeutic Outcomes

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. In either event, the 2016 DEA guidance letter is not currently published or otherwise available on DEA’s guidance portal. [4]

Nurses

Nurses Pharmacy Regulations Therapies

Drug Discovery Digest

FDA approves first interchangeable biosimilar insulin product for treatment of diabetes

Pharmacists in Florida (and Elsewhere): Waive Prescribing Red Flags at Your Peril

Trending Sources

Electronic Controlled Substance RXs: Signed, Sealed, Delivered But Can’t be Filled

European Commission vs Big Pharma, or profit vs access?

Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms

Prescribing Red Flags and Suspicious Controlled Substance Orders: Current Cautionary Tales

Why, Who, When, Where and More: New Draft Guidance on Notifying FDA about Discontinuance or Interruption in Manufacturing

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

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

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

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

CMS Publishes Grab Bag of Proposed Changes to the Medicaid Drug Rebate Program

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

DEA’s Expected Guidance: It Should Reduce Current “Pain” at the (Intrathecal Pain) Pump Dispensing Process and Improve Therapeutic Outcomes

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