Bioequivalence Archives

Safety Reporting Requirements - Lachman Blog

FDA Issues Two Guidance Documents to Help Sponsors with Safety Reporting Requirements

By Bob Pollock Dec 15, 2025 ANDAs Bioequivalence IND NDA

In an email announcing the two new guidances, the FDA said, “[t]he first guidance titled Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices is intended for investigators, industry, and institutional review boards (IRBs). This final guidance provides recommendations to help clinical investigators comply with the safety reporting requirements for investigational new drug application […]

Dec

Series of New and Revised PSGs Issued Today

By Bob Pollock Dec 04, 2025 ANDAs Bioequivalence PSGs Regulatory Affairs

Today, the FDA issued 44 new and 37 revised draft product specific guidances (PSGs) outlining FDA’s current thinking on the requirements for establishing bioequivalence to reference listed drugs or reference standards. None of the guidance documents were finalized in the current listings. According to the FDA Email, the 81 guidance documents included (and yes, I […]

Nov

Guidance on Waiver of pH Adjusters Publishes - Lachman Blog

The Day After the Government Reopens, Final Guidance on Waiver of pH Adjusters Publishes

By Bob Pollock Nov 14, 2025 Bioequivalence Generics OGD Regulatory Affairs

The OGD got back to business right away after the government reopened by publishing the final guidance titled Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Guidance for Industry (here). The issue of changing pH-adjuster ingredients for the purposes of creating a generic formulation of […]

Nov

New and Revised PSGs Show Off Busy Bees at FDA During Shutdown

By Bob Pollock Nov 07, 2025 ANDAs Bioequivalence Generics OGD PSGs Regulatory Affairs

It is no small task to get a guidance document issued by the FDA in normal operating times but in the face of the longest government shutdown in history, the issuance of 76 PSGs (32 new and 44 revised) is nothing short of amazing. Yesterday, the FDA announced the new and revised guidance documents’ availability […]

Oct

FR Notice Announces New and Revised PSGs - Lachman Blog

Shutdown Begins – FR Notice Announces New and Revised PSGs – Surprise, Surprise

By Bob Pollock Oct 01, 2025 ANDAs Bioequivalence Generics OGD PSGs Regulatory Affairs

In today’s pre-publication Federal Register notice (here), the FDA announced publication of 17 new product specific guidances (PSGs) and 58 revised PSGs. This is the first release of PSGs since the May 20, 2025 dump of 36 new and 15 revised PSGs. Not only is this good news for developers of generic drugs, release of the […]

Sep

Another Bill introduced to Solve the Q1/Q2 Dilemma

By Bob Pollock Sep 19, 2025 ANDAs Bioequivalence FDA Generics OGD Regulatory Affairs

An Association for Accessible Medicines release (here) reports that the AAM “thanked the House Energy and Commerce Committee for marking up Q1/Q2 legislation previously introduced by Representatives by Congressmen [sic] Dunn of Florida and Mullin of California. The bipartisan and bicameral legislation was included in the 2024 year-end spending bill and was reintroduced this Congress.” […]

May

PSGs Released Today

By Bob Pollock May 20, 2025 ANDAs Bioequivalence Generics OGD PSGs Regulatory Affairs

We mentioned the delay in publication of OGD statistics a couple of days ago in our post here. There has also been a delay, caused by the reduction in force at the OGD, of the publication of quarterly product-specific guidance documents (PSGs), but now the wait is over! According to the FDA announcement here, “[t]oday’s […]

Apr

Asking FDA to Take Another Look - What’s New with RfR - Lachman Blog

What’s New with Requests for Reconsideration?

By Rebecca Welton Apr 17, 2025 ANDAs Bioequivalence Generics OGD Regulatory Affairs Statistics

On Day 1 of the Generic Drug Forum, the topic of submitting a Request for Reconsideration (RfR), as first provided for in GDUFA II and updated in GDUFA III, was presented. The FDA’s Office of Generic Drugs (OGD) had two presentations on this topic, one from Joe Shin, PharmD, and one from Dr. Yi Zhang. In his presentation, Dr. Shin […]

Apr

Do You Trust What Your Drug Applications are Saying?

By Scott Deckebach Apr 14, 2025 ANDAs Bioequivalence Biologics Biosimilars Compliance Data Integrity NDA Regulatory Affairs

Trust is essential to everything we do in the pharmaceutical industry. Developing new drugs requires speaking the global language of data, which is meaningless without trust. Toxicity, efficacy, bioequivalence, and bioavailability are key measurements of drug safety and effectiveness, all spoken in the language of data. These only have meaning if there is trust. Imagine […]

Apr

Is the “Price Is Right” Game Over for Many Generic Drugs?

By Bob Pollock Apr 11, 2025 ANDAs Bioequivalence Generics OGD Regulatory Affairs

On April 10, U.S. Senators Maggie Hassan (D-NH), Rand Paul (R-KY), John Hickenlooper (D-CO), and Mike Lee (R-UT) reintroduced bipartisan legislation S. 1302 that would prevent the FDA and industry from participating in a protracted guessing game regarding the amount of an inactive ingredient for a subset of generic drugs that are either required by regulation […]

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