Article, Clinical Pharmacology and Licensing

Women in STEM with Kristina Torfgard

Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

Pharma Companies

Pharma Companies Licensing Licensing Disease

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

OCTOBER 6, 2023

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA.

FDA

FDA Biosimilars Science Production

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

Agency IQ

MAY 3, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Regulations Clinical Trials

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

Agency IQ

JUNE 16, 2023

0910-AI26 September 2023 March 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

Regulations

Regulations FDA Science Production

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

Agency IQ

SEPTEMBER 29, 2023

The following PDUFA dates were obtained from publicly available sources. The following commitments are due within the next two months, minus any commitments the FDA has already met (to our knowledge).

FDA

FDA Science Regulations Production

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

Agency IQ

JUNE 2, 2023

The following PDUFA dates were obtained from publicly available sources.

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

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

FDA

FDA Science Regulations Production

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

Agency IQ

JULY 8, 2024

The following PDUFA dates were obtained from publicly available sources.

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

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 (..)

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

Agency IQ

MARCH 1, 2024

FDA March 13 BLA Regulation FDA’s Biologics License Applications and Master Files rule becomes effective FDA March 25 Quality Management Maturity Deadline to participate in the Quality Management Maturity Prototype Assessment Protocol Evaluation Program. The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Clinical Trials Regulations

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

Agency IQ

DECEMBER 1, 2023

December 2023 Clinical Holds in Medical Device Investigations (Proposed Rule) The proposed rule would create procedures for suspending, i.e., imposing a hold (a “clinical hold”) on, a clinical investigation of a medical device. The following PDUFA dates were obtained from publicly available sources.

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

CDRH FY2024 Guidance Agenda Device software Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers CDRH Final By 10/1/24 Priority B List CDRH FY2024 Guidance Agenda Post-approval reporting 3D Printing Medical Devices at the Point of Care CDRH Draft By 10/1/24 New on CDRH’s guidance agenda. Priority B List.

FDA

FDA Science Biosimilars Clinical Trials

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

JULY 12, 2024

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Regulations

Regulations FDA Science Production

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Agency IQ

FEBRUARY 2, 2024

The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Clinical Trials Regulations

Drug Discovery Digest

Women in STEM with Kristina Torfgard

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

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

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

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 June 2023

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 July and August 2024

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 March and April 2024

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

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

Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

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