IND 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 […]

Nov

Rise of Bio-Incubator Spaces - Lachman Blog

The Rise of Bio-Incubator Spaces: Redefining Asset Development in Life Sciences

By Patrick Day Nov 26, 2025 Biologics Biosimilars BLA Compliance IND NDA

The life-sciences industry has long been synonymous with high barriers to entry. Traditional research and development (R&D) models demand enormous capital investment, specialized infrastructure, and a deep understanding of regulatory compliance. For startups and innovators, these requirements often translate into years of fundraising and risk before a single product reaches the market. However, the emergence […]

Nov

Debarments Continue – How Many and for What?

By Bob Pollock Nov 24, 2025 ANDAs Biologics Biosimilars BLA Compliance Data Integrity FDA Generics IND NDA

The process of debarment began after the generic drug scandal in the late 1980s and the FDA continues to use this process to preclude individuals from participating in a variety of activities, including drug development, manufacture, clinical studies in support of drug applications, and importing drugs into this country if they are have been convicted […]

Nov

Diverse group of smiling businesspeople clapping in office training. Team of professional colleagues cheering and celebrating together while learning in workshop. Attending a seminar for marketing

Richard Pazdur, M.D. Named CDER Director

By Bob Pollock Nov 11, 2025 Biosimilars FDA Generics IND NDA Regulatory Affairs

Even after he originally said that he wasn’t interested in the job, Richard Padzur, M.D., a long-time (26-year!) veteran of the FDA, was named Director of the Center for Drug Evaluation and Research. As the founding director of the FDA’s Oncology Center of Excellence and in his tenure leading the Oncology Division, Dr. Padzur has been […]

Oct

If You Must Remit, You Can’t Submit = Big Problem for Industry

By Bob Pollock Oct 30, 2025 ANDAs Biologics Biosimilars BLA FDA Generics IND NDA OTC Regulatory Affairs

As we near the end of October 2025, the first month of new FY 2026, and as FDA appropriations languish in our dysfunctional Congress, the number of fee-paying submissions submitted to FDA so far in the new Fiscal Year 2026 = 0. That’s right nada, nil, zero, zilch, none. You can count the number on […]

Feb

Do You Know Your Product’s Impurity Profile?

By Paul Mason, PhD. Feb 16, 2024 ANDAs Biologics Biosimilars BLA FDA Generics Impurity Profile IND NDA OGD Regulatory Affairs

ICH Q7 refers to the need to establish the impurity profile for an Active Pharmaceutical Ingredient (API): “An impurity profile describing the identified and unidentified impurities present in a typical batch produced by a specific controlled production process should normally be established for each API. The impurity profile should include the identity or some qualitative […]

Jun

FDA Guidance on Psychedelic Drugs - Lachman Consultants

Take a Trip for Mental Health? You May Not Have to Pack Your Bags!

By Bob Pollock Jun 26, 2023 IND NDA

Did Timothy Leary have it right? There is more interest these days in research into the use of psychedelic drugs as a therapy for many conditions and the FDA is getting on board by publishing a guidance document entitled Psychedelic Drugs: Considerations for Clinical Investigations Guidance for Industry (here). The guidance notes that the “U.S. […]

Dec

FDA Proposes Rule to Change the IND Annual Report

By Bob Pollock Dec 08, 2022 Biologics Compliance FDA IND New Drugs Safety

Today’s pre-publication of the Federal Register contains a proposed rule (here) that will require the expansion of the current IND annual report. “Current § 312.33 requires sponsors that have an IND in effect to submit an annual report that must contain individual study information, which generally includes brief summaries of the status of each ongoing […]

Sep

Right to Try Final Rule for Reporting Under the Act To Publish On Wednesday

By Bob Pollock Sep 13, 2022 FDA IND Investigational drugs Regulatory Affairs

In today’s prepublication of the Federal Register appears the final rule entitled Annual Summary Reporting Requirements Under the Right to Try Act (here). The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina, Right to Try Act of 2017 (Right to Try Act), was signed into law on May 30, 2018. This Act provides an […]

Aug

Revised Q&A Guidance on Charging for Investigational Drugs Issued by FDA

By Bob Pollock Aug 23, 2022 Charging FDA IND Investigational drugs Regulatory Affairs

While FDA has allowed charging for investigational drugs since the 1987 “Charging Rule” went into effect, the Agency has been responding to questions from industry ever since. In 2009, the FDA revised the Charging Rule itself. The revised guidance (here) discusses these changes and notes that the “FDA’s regulations on charging for investigational drugs under […]

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