NDA Archives - Page 8 of 24 - Lachman Consultant Services, Inc.

PostMarketing Study Requirements - Lachman Consultants

What Constitutes “Good Cause” for Noncompliance with PostMarketing Study Requirements?

By Bob Pollock Jul 14, 2023 BLA NDA Post Marketing studies and reports

The FDA answers this question in a newly released guidance titled Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act (here). “[H]olders of applications for human prescription drugs (hereafter applicants) who are required to conduct postmarketing studies or clinical trials under section 505(o)(3) of the […]

Jul

First OTC Contraceptive Pill Approved

By Bob Pollock Jul 13, 2023 Approvals NDA OTC Regulatory Affairs

I remember working part-time as a pharmacist when I was at FDA and there were only a few prescription oral contraceptives that were available for dispensing at that time. If you had asked then (1984) if I thought that there would ever be an OTC version of an oral contraceptive available, I would have bet […]

Jul

ISPE’s Biotech Conference Provides Important Insights

By John Darby Jul 10, 2023 Biologics Biosimilars BLA Compliance NDA Regulatory Affairs

The ISPE 2023 Biotechnology Conference was held from 26 to 27 June in Dublin, Ireland. Much of the focus of the conference was Cell and Gene Therapy and Advanced Therapy Medicinal Products (ATMPs), terms used in the US and EU for a range of emerging therapies and products in various stages of development. At the […]

Jul

MaPP 5014.1 - Understanding CDER’s Risk‑Based Site Selection Model - Lachman Consultants

MaPP for Site Surveillance Inspection Procedure Gets a Facelift

By Bob Pollock Jul 06, 2023 BLA Compliance Dietary Supplements FDA Generics NDA OTC

The FDA has just revised its MaPP 5014.1 titled Understanding CDER’s Risk‑Based Site Selection Model. Remember, MaPP stands for Manual of Policy and Procedures, and MaPPs instruct internal FDA staff on proper procedures. The FDA publishes these MaPPs to provide greater transparency to stakeholders so they can better understand how the Agency does something or […]

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. […]

Jun

Supply Chain Risk and Data Management Poised to Take a Leap Forward

By Patrick Day Jun 09, 2023 ANDAs Compliance Data Integrity Drug Shortages FDA ICHQ9 NDA Regulatory Affairs Risk Management Supply Chain Resilience

In a complete supply chain, one site’s lag measure is another site’s lead measure. As important as data integrity is to product quality decisions at the site, data risks in the supply chain can affect availability of product to patients. As mentioned in a previous Lachman blog (here), drug shortages are the preeminent risk for […]

May

Nitrosamines – The Wait Continues, But You Can Help

By Jennifer Leaming May 31, 2023 ANDAs FDA Generics Impurities NDA Nitrosamines

Many of our clients and readers have NDAs, ANDAs, and supplements that are still pending approval due to a “complex regulatory issue” where the FDA has missed its goal date; in some cases, this missed date was many months ago. There can be several reasons for this type of delay but, as we have blogged […]

May

PMI – Add That to Your List of Acronyms as FDA Publishes a New Proposed Rule

By Bob Pollock May 30, 2023 ANDAs BLA Generics Labeling NDA

Prescription Medication Information (PMI) will, if FDA has its way, replacing medication guides and other information provided to patients. The goal of the new PMI is to “highlight essential information that the patient needs to know about the prescription drug product and basic directions on how to use the product. The pre-publication of the proposed […]

May

Join Lachman Consultants (Ireland) at the 2023 MedTech Conference from May 30th – June 1st

By Webmaster Lachman May 30, 2023 ANDAs FDA NDA

We are pleased to announce that Lachman Consultants (Ireland) will participate in this year’s MedTech Forum as a Gold sponsor. Held from May 30 – June 1, 2023, in Dublin, Ireland, the three-day event is the largest health and medical technology industry conference in Europe. The Lachman Consultants team will be represented by: Frances Zipp, […]

May

Are FDA’s Approval Authority and Agency Deference at Risk? Mifepristone Ruling and Beyond

By David Petshaft and Jessica Soderberg May 23, 2023 ANDAs Approvals FDA Generics NDA Regulatory Affairs

The Food and Drug Law Institute (FDLI) recently held its 2023 Annual Conference on May 17-18 in Washington, D.C. where professionals from the food, drug, medical device, biologics, and tobacco industries gathered to hear important updates and panel discussions from a distinguished group of industry and FDA speakers. The Conference commenced with keynote addresses by […]

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NDA

What Constitutes “Good Cause” for Noncompliance with PostMarketing Study Requirements?

First OTC Contraceptive Pill Approved

ISPE’s Biotech Conference Provides Important Insights

MaPP for Site Surveillance Inspection Procedure Gets a Facelift

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

Supply Chain Risk and Data Management Poised to Take a Leap Forward

Nitrosamines – The Wait Continues, But You Can Help

PMI – Add That to Your List of Acronyms as FDA Publishes a New Proposed Rule

Join Lachman Consultants (Ireland) at the 2023 MedTech Conference from May 30th – June 1st

Are FDA’s Approval Authority and Agency Deference at Risk? Mifepristone Ruling and Beyond

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