Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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Agency IQ

AUGUST 2, 2024

An earlier iteration of that report detailed how the agency wanted to change some of its practices surrounding the publication of guidance documents. However, the draft document was somewhat FDA-focused, and industry asked the agency to incorporate other ideas into the final version. This is what OIRA is currently reviewing.

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Agency IQ

APRIL 26, 2024

Updated guidance on promotional labeling for biosimilars and interchangeables emphasizes a similar approach Today, the FDA issued a revised draft guidance on the development of promotional labeling for biosimilars, reference products, and—newly—interchangeable products. regarding its administration, preparation, storage, or safety).

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Agency IQ

JULY 8, 2024

In early June, we’re expecting to see what the FDA will allow life sciences companies to do in this fight as it releases a new draft guidance document. In early June, we’re expecting to see what the FDA will allow life sciences companies to do in this fight as it releases a new draft guidance document.

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FDA Law Blog: Biosimilars

AUGUST 9, 2023

Two licensed pharmacists must directly communicate the transfer. As with other required controlled substance records, electronic records documenting EPCS transfers must be maintained for two years from the transfer date by both the transferring and receiving pharmacies. cannot be altered during the transmission.

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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. It also states that “[t]he pharmacist shall record any related information indicated by a licensed health care practitioner.” Id.

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Agency IQ

JANUARY 19, 2024

Seventeen products were orphan drugs, fourteen were generics and eight were biosimilars. Reviews of orphan medicines and biosimilars have remained stable over the past three years. There were eight biosimilars reviewed in 2023, which is comparable to 2021 (seven) and 2022 (eight), but lower than 2020, which saw 12 biosimilars reviewed.

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Agency IQ

JUNE 2, 2023

We’ve also included documents that are actively under White House review, which often takes several weeks (or months). Note: If a link no longer works, it is likely because OIRA has since cleared the document.) This is what OIRA is currently reviewing. Note: If a link no longer works, it is likely because OIRA has since deleted it.)

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Agency IQ

MAY 3, 2024

FDA’s Diversity Action Plan guidance: The FDA’s hotly-anticipated revised draft guidance document is currently under review at the White House’s Office of Information and Regulatory Affairs (OIRA), and we anticipate that it will be published over the next two months. The following PDUFA dates were obtained from publicly available sources.

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Agency IQ

SEPTEMBER 22, 2023

According to that document, PDURS are “software applications disseminated by or on behalf of drug sponsors for use with one or more of their prescription drug products.” Similarly, the agency simply notes that it would review potential biosimilar or interchangeable products consistent with its existing regulatory expectations for licensure.

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The Pharma Data

MAY 6, 2021

ENVI calls on the Commission to “revise the use of supplementary protection certificates based on technological and scientific advances to prevent generic and biosimilar medicines from becoming less competitive inside and outside the EU.”. . Draft Report. . Denmark posts guidance on decentralizing clinical trials. EMA Report. .

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FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

. § 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R.

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FDA Law Blog: Biosimilars

MARCH 13, 2024

The PTE application states “[u]nder the terms of the AMENDED AND RESTATED DEVELOPMENT AND COMMERCIALIZATION LICENSE AGREEMENT between Pfizer Inc. exclusively licensed U.S. However, an exclusive license is not an authorization to rely on the activities of the marketing applicant for a PTE application. and OPKO Ireland Ltd.

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Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below. In addition, CDER’s guidance agenda only reflects documents that are under development.

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The Pharma Data

JULY 27, 2021

Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

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Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. This list is known as the FDA’s “guidance agenda.”

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The Pharma Data

APRIL 30, 2021

percent on an operational basis, due to biosimilar competition. a leading clinical-stage CRISPR genome editing biotechnology company, announced that they have entered into a collaboration and license agreement for the research and development of chimeric antigen receptor (CAR)-T cell therapeutics. percent on a reported basis, or 12.6

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Agency IQ

SEPTEMBER 29, 2023

That will have meant that FDA flagrantly missed its deadline to issue a guidance document related to medical countermeasure submissions and the use of Drug Master Files for platform technologies, which was due June 24, 2022. FDA is also due to revise 24 other guidance documents at that time. This is what OIRA is currently reviewing.

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Agency IQ

JUNE 29, 2023

We’ve also included documents that are actively under White House review – a process which often takes several weeks (or months) to conclude. Note: If a link no longer works, it is likely because OIRA has since cleared the document.) This is what OIRA is currently reviewing.

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Agency IQ

OCTOBER 27, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published. FDA is also due to revise 24 other guidance documents at that time. AgencyIQ November 18 Shutdown (?)

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Agency IQ

DECEMBER 1, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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FDA Law Blog: Biosimilars

DECEMBER 11, 2023

FDA’s assumption that 50% of the tests will be exempt is particularly baffling because the laboratories are ones licensed to perform high complexity tests. OHT-7’s well documented meltdown during the COVID-19 public health emergency should serve as an object lesson. 24] These submissions all related to a single disease.

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The Pharma Data

SEPTEMBER 16, 2020

Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

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Agency IQ

JUNE 2, 2023

The PMI itself would be a one-page document that would include a standardized format and content, and would be subject to FDA review and approval. However, only licensed blood establishments would be required to submit PMI to FDA for approval.” The format of the PMI : At just one page (8.5×11

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The Pharma Data

FEBRUARY 4, 2021

Percent on an Operational Basis, Due to Biosimilar Competition; Global Skyrizi Net Revenues Were $1.590 Billion; Global Rinvoq Net Revenues Were $731 Million. percent on an operational basis, due to biosimilar competition. Humira Net Revenues Were $16.112 Billion, an Increase of 8.4 Percent on a Reported Basis, or 12.5

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The Pharma Data

SEPTEMBER 20, 2020

Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

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The Pharma Data

NOVEMBER 9, 2020

Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

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The Pharma Data

DECEMBER 21, 2020

Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

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Agency IQ

SEPTEMBER 1, 2023

The MHRA notes that the new pathway will be parallel to its innovation pathway (the Innovative Licensing and Access Pathway , or ILAP), which integrates “early regulatory advice with health technology assessment advice.” according to the consultation document. Japan, Switzerland, Singapore and the U.S. market more quickly. or E.A.A.

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Agency IQ

JULY 28, 2023

It’s also possible that some of FDA’s commitments – and especially things like new guidance documents – might get delayed later into October. That’s because significant guidance documents typically require review and approval by the White House’s Office of Information and Regulatory Affairs (OIRA) prior to publication.

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