Biosimilars, Licensing, Pharmaceuticals and Pharmacy

Hyman, Phelps & McNamara, P.C. (HP&M) is Pleased to Announce the Addition of Sara M. Keup as the new State Licensing Regulatory Expert for the Firm’s Licensing Practice

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years. Keup has joined the firm to assist attorneys Karla L.

Licensing

Licensing Licensing Pharmacy Regulations

NEW: The 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Drug Channels

OCTOBER 11, 2022

I am pleased to announce our new 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. Drug Distribution Industry Expands as COVID-19 Disruption Fades and Biosimilars Boom (press release) We’re offering special discounted pricing if you order before October 21, 2022!

Pharmaceuticals

Pharmaceuticals Biosimilars Licensing Licensing

NOW AVAILABLE: The 2023–24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Drug Channels

OCTOBER 10, 2023

I am pleased to announce our new 2023–24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. we analyze the IRA’s likely consequences for wholesalers and the overall pharmaceutical business. and Section 6.4.3.

Pharmaceuticals

Pharmaceuticals Specialty Pharmacies Pharmacy Biosimilars

NEW: The 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Drug Channels

OCTOBER 5, 2021

I am pleased to announce our new 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors , available for purchase and immediate download. pharmaceutical distribution industry. analyzes how marketplace dynamics of provider-administered biosimilars affect wholesalers’ gross margins. Section 4.4.

Pharmaceuticals

Pharmaceuticals Biosimilars Licensing Licensing

Available for Preorder: The 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Drug Channels

SEPTEMBER 12, 2023

On October 10, 2023, Drug Channels Institute will release 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors. pharmaceutical distribution industry. If you have any questions before purchasing a license to the report, please email me ( afein@drugchannels.net ). d/b/a Drug Channels Institute.

Pharmaceuticals

Pharmaceuticals Pharmacy Biosimilars Licensing

European Commission vs Big Pharma, or profit vs access?

Drug Discovery World

MARCH 29, 2023

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? He pointed out that Europe was the first region to approve biosimilars. You can compare timelines.

Clinical Trials

Clinical Trials Biosimilars Pharma Companies Production

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

Livornese — On February 6, 2024, FDA issued a draft guidance titled Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.

FDA

FDA Production Marketing Pharmacy

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

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

Manufacturers must also ensure that all electronic FDA listings and all NDC listings with the electronic database vendors used to process pharmacy claims, including information about discontinued drugs, are up to date for all applicable drug and selected drug NDCs. state pharmaceutical assistance programs). 1395w-114c(b)(4)(B)(i).

Compliance

Compliance Pharmacy Drugs Licensing

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

Agency IQ

SEPTEMBER 29, 2023

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The rule, will also, if finalized, address communication with State boards of pharmacy.

FDA

FDA Science Regulations Production

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. Priority B List.

FDA

FDA Science Biosimilars Production

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

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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

Based on the results of its evaluation of nominated categories of drug products to date, as well as consultation with the Pharmacy Compounding Advisory Committee (PCAC), FDA is also proposing to include certain categories of drug products on these lists. The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Production

Drug Discovery Digest

Hyman, Phelps & McNamara, P.C. (HP&M) is Pleased to Announce the Addition of Sara M. Keup as the new State Licensing Regulatory Expert for the Firm’s Licensing Practice

NEW: The 2022–23 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Trending Sources

NOW AVAILABLE: The 2023–24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

NEW: The 2021–22 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

Available for Preorder: The 2023-24 Economic Report on Pharmaceutical Wholesalers and Specialty Distributors

European Commission vs Big Pharma, or profit vs access?

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

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

CMS Finalizes Guidance on Medicare Part D Manufacturer Discount Program

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

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

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

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

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