Biologics Archives

Draft Guidance Issued on Device Presentations for Biosimilar and Interchangeable Biosimilar Products

By Bob Pollock Aug 03, 2026 Biologics Biosimilars Regulatory Affairs

On July 30, 2026, FDA issued a draft guidance (here) titled Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts Guidance for Industry. FDA goes into detail regarding what they term “presentation” (container closure systems (e.g., vials) and device constituent parts of combination products) and describes how firms should address […]

Jul

PDUFA User Fees Announced for 2027 – Surprise! Surprise!

By Bob Pollock Jul 29, 2026 Biologics BLA NDA PDUFA Regulatory Affairs

The announcement in the prepublication of the Federal Register of the new FY 2027 PDUFA user fees for NDAs and BLAs might be a bit of a pleasant surprise to sponsors as the decrease in fees is something we usually do not see. Perhaps it is due to the significant staff reductions seen during the […]

Jul

Get Your Reading Glasses On – CDER Guidance Plans for 2026 Cite 85 Documents

By Bob Pollock Jul 17, 2026 ANDAs Bioequivalence Biologics Biosimilars BLA Compounding Generics Labeling NDA OGD PSGs Regulatory Affairs Unapproved Drugs

With four and a half months remaining in fiscal year 2026, the Center for Drug Evaluation and Research (CDER) has published the list of 85 new or revised guidance documents that it plans to release this year! The document (here) categories along with the number of anticipated guidances are as follows: Administrative/Procedural – 8 Artificial […]

Jul

HHS Unified Rule Agenda for 2026

By Bob Pollock Jul 08, 2026 ANDAs Biologics Biosimilars BLA Compounding Devices Dietary Supplements Labeling NDA Regulatory Affairs

The list is long (here) and there are some interesting regulatory items found in the agenda for FDA. Take some time and peruse them all as I will just highlight a few items of interest in this post. Here are some of the proposed rules that caught my attention: Current Good Manufacturing Practice for Outsourcing […]

Jun

One Adequate and Well-Controlled Study – Be Sure You Meet with the FDA!

By Bob Pollock Jun 25, 2026 Biologics BLA IND NDA

The new draft guidance “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products” (here) provides the industry with a foundation for providing one adequate and well-controlled study with appropriate confirmatory supporting data to satisfy the Agency’s requirement for demonstrating safety and efficacy. While this may, on its face, appear to be a boon […]

Jun

Compliance With Clinical Trials Posting – Understanding the Requirements

By Bob Pollock Jun 23, 2026 Biologics Biosimilars Compliance Devices IND NDA Regulatory Affairs

Over the last six to eight months, the FDA’s activity regarding compliance with the required posting of ongoing and completed clinical trials has significantly increased, as evidenced by the issuance of multiple warning letters and letters of non-compliance to sponsors and/or principal investigators. To assist responsible parties in complying with the requirement to post on […]

Jun

If a Product Is Found to Be Safe, Should We Just Forget About Efficacy? Not On My Watch!

By Bob Pollock Jun 03, 2026 Approvals Biologics Biosimilars BLA NDA Regulatory Affairs

On June 2, 2026 in The Wall Street Journal, Charles L. Hooper and David R. Henderson wrote “…Remove efficacy from the FDA’s approval process and focus on safety alone. That would improve doctors’ ability to match patients with the best drugs and help Americans live longer, healthier lives. Medicine is a matchmaking exercise in which potentially beneficial drugs […]

May

FDA Issues Draft Guidance Aimed at Reducing Non-Clinical Animal Studies

By Bob Pollock May 29, 2026 Biologics BLA IND NDA Regulatory Affairs

Today, the FDA published a draft guidance titled “Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products: Guidance for Industry,” aimed at implementing streamlined approaches for nonclinical safety assessments of certain oncology pharmaceuticals. The draft guidance can be found here. The document provides some interesting background on the evolution of the Agency’s thinking […]

May

An Interesting Issue That May Impact FDA and Industry

By Bob Pollock May 27, 2026 ANDAs Biologics Biosimilars BLA Confidentiality Device NDA

A Federal Register (FR) notice that appeared on today’s pre-publication page discusses a request for comments on a draft nondisclosure agreement (NDA) for federal employees. The notice (here) discusses the proposed NDA to affirm “[f]ederal employees’ acknowledgment of, and agreement to comply with, current legal obligations to safeguard non-public, confidential, or proprietary information, created or […]

May

TIDES Conference – Recap of Sessions

By Mrinmoy Nag May 19, 2026 Advanced Therapies Biologics Peptides

I had the privilege of attending the TIDES conference in Boston from May 12th to 14th. TIDES is always a standout event where attendees can hear about the latest advances in oligonucleotide and peptide therapeutics, along with valuable insights into the evolving landscape of drug development and manufacturing. This year was no exception, with a strong […]

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Biologics