Biosimilars, Document and Drug Development

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

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.

FDA

FDA Science Regulations Biosimilars

A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

We have heard over and over again how the potential for a priority review voucher has allowed small companies with limited resources to invest in the development of drugs for rare pediatric diseases. We heard and felt the anxiety from many of our clients about the uncertainty this caused. After all, this is what incentives are for.

Disease

Disease FDA FDA Approval Government

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

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FDA’s Diversity Action Plan guidance: The FDA’s hotly-anticipated revised draft guidance document is currently under review at the White House’s Office of Information and Regulatory Affairs (OIRA), and we anticipate that it will be published over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.

FDA

FDA Science Regulations Clinical Trials

Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

FDA Law Blog: Biosimilars

AUGUST 23, 2023

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

Production

Production Clinical Trials FDA Drugs

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

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.

FDA

FDA Science Regulations Production

Article EMA Thank You What we expect European regulators to do in July 2024

Agency IQ

JULY 8, 2024

Negative *Biosimilar **Generic Notable public consultation periods and calls for evidence Below are various deadlines regarding European policy, such as public registers, drafts, reflection papers, concept papers, and guidance documents expected to close into Q3 2024.

Regulations

Regulations Pharmaceuticals Production Vaccine

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

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.)

FDA

FDA Science Regulations Production

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

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.

FDA

FDA Science Regulations Production

Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?

Agency IQ

JUNE 9, 2023

Other orphan drugs, which, by definition, address an unmet medical need, “only” receive 9 years of market exclusivity. Reduced market exclusivity would foster generic and biosimilar competition through earlier market access. Generic and biosimilar developers benefit from earlier market entry.

Marketing

Marketing Regulations Biosimilars Drugs

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

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. Some of those documents may also take years to be completed.

FDA

FDA Science Biosimilars Clinical Trials

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

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 (?)

FDA

FDA Science Regulations Production

Lilly and Amgen Announce Manufacturing Collaboration for COVID-19 Antibody Therapies

The Pharma Data

SEPTEMBER 17, 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.

Therapies

Therapies Production Government Disease

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

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.”

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

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.)

FDA

FDA Science Regulations Production

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3. and PART 3½)

FDA Law Blog: Biosimilars

MARCH 13, 2024

1001 and any other applicable criminal statute, and violations of the provisions of this section may jeopardize the probative value of the paper.

FDA

FDA FDA Approval Production Marketing

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

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.

FDA

FDA Science Biosimilars Regulations

Drug Discovery Digest

Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

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

Article EMA Thank You What we expect European regulators to do in July 2024

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

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

Article EMA Thank You What will the orphan drug market exclusivity haircut mean for industry?

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

Lilly and Amgen Announce Manufacturing Collaboration for COVID-19 Antibody Therapies

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

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

Surely You Must be Kidding, PTO?!? “No, and Don’t Call Me Shirley!” – The Seemingly Slapstick (But Yet Unfunny) World of Recent Patent Term Extension Decisions (PART 3. and PART 3½)

Analysis Life Sciences Thank You Everything the FDA is planning to do in Q3 2023

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