OGD Archives - Page 5 of 13 - Lachman Consultant Services, Inc.

Revision 1 of Risk information in Promotional Materials and Ads Hits the Street

By Bob Pollock Dec 12, 2023 ANDAs Biologics Biosimilars BLA Compliance Generics Labeling NDA OGD Regulatory Affairs

Yesterday, the FDA issued the first revision of the Guidance titled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements (here). This Guidance covers the following four topics: Providing quantitative efficacy or risk information for the control group, when applicable; Presenting probability information in terms of absolute frequencies, percentages, and relative […]

Dec

Say Goodbye to Ciprofloxacin 100mg Tablets!

By Bob Pollock Dec 07, 2023 ANDAs Efficacy Generics NDA OGD

An FDA notice contained in the Federal Register (FR) notice prepublication pages today (here) has put the final kibosh on the use of ciprofloxacin 100mg tablets due to current evidence demonstrating that the increased resistance of Escherichia coli (E. coli) to the low strength of ciprofloxacin makes it no longer effective for treatment of acute […]

Nov

Woman on the phone looking confused at a broken computer

Computer Problems Still Plague ANDA Approval Postings

By Bob Pollock Nov 22, 2023 ANDAs Approvals FDA Generics OGD Regulatory Affairs

Not sure what is taking the FDA so long to fix the system “glitch” in reporting ANDA approval actions, but this has been going on for quite a while. Here we are, the day before Thanksgiving, and there are only 14 full ANDA approval actions and 9 tentative approval actions listed in the available FDA […]

Nov

Establishing a CCS Foundation for Cleaning Validation

By Paul Dexter Nov 22, 2023 ANDAs Biologics Biosimilars BLA Cleaning validation Compliance Contamination Control Strategy NDA OGD Regulatory Affairs

Bring up the recently updated and finalized EU Annex 1 – Manufacture of Sterile Medicinal Drug Products (here) in polite pharmaceutical water cooler conversation and a frequent topic that comes up is the Contamination Control Strategy (CCS) language. Buzzwords abound for a “holistic”, “global”, or “wholesale” CCS to be incorporated into all elements of aseptic […]

Nov

Full FY 2023 ANDA Statistical Reports Arrived on November 1, 2023 – Let’s Take a Look!

By Bob Pollock Nov 01, 2023 ANDAs Approvals FDA Generics OGD Regulatory Affairs Statistics

First, let’s look at September 2023 statistics (end of FY 2023), then we will comment on the full FY stats. As we reported here, September looked to be a slow month, and it was. While we missed a few full-approval actions (we reported forty-one), the OGD actually issued forty-four, and ten tentative-approval actions. Remember, the Agency […]

Oct

EU Issues Communication Addressing Medicine/Drug Shortages

By Patrick Day Oct 30, 2023 ANDAs Biologics Biosimilars BLA Compliance NDA OGD Regulatory Affairs Supply chain

The EU has continued its advancement of initiatives and intentions to combat the drug shortage problem. The latest communication is titled “Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Addressing medicine shortages in the EU” (here). This is a deep dive […]

Oct

The Posting of ANDA Approval Actions Is Still a Problem – No Word on Time for a Fix

By Bob Pollock Oct 25, 2023 ANDAs Approvals Generics OGD Regulatory Affairs Statistics

Once again, with October approval action postings surprisingly low, I confirmed that the FDA is still having trouble with its internal IT systems that generate this information and populate certain databases. While it does not appear to be impacting data regarding NDAs, the ANDA postings are spotty at best. The word came back from OGD […]

Oct

Close-up medical syringe with a vaccine.

Drug-Device Combinations for Generic Drugs: A Good Session at AAM’s GRx+Biosims Conference

By Bob Pollock Oct 12, 2023 ANDAs Combination Products Device Drug-device OGD Regulatory Affairs

Remember the good old days, when a dosing spoon or cup was dispensed with liquid medication and a product in a prefilled syringe was just a drug? Well, we know now that those days are over, and maybe they should be. The presentation by three FDAers, Markham Luke, MD, PhD, Karyn L. Berry, MD, MPH, and […]

Oct

August 2023 Official OGD Statistics Released

By Bob Pollock Oct 11, 2023 ANDAs Approvals Generics OGD Statistics

August was an even better month than we predicted in our post on September 8th (here). There were actually 98 (instead of 96) full approval actions and 12 tentative approval actions for a total of 110 approval actions. The two (2) approvals missed likely were at the end of the month when we first discovered […]

Oct

More from AAM’s GRx-Biosims Conference: OGD Stats We Don’t Always See

By Bob Pollock Oct 10, 2023 ANDAs OGD Regulatory Affairs Statistics

Just wanted to catch you up on a session related to generic drugs that I found particularly interesting presented by Edward “Ted” Sherwood, Director of Regulatory Operations, OGD, on some statistical metrics that are quite impressive. Among other things, the presentation outlined missed GDUFA goal dates, but was not inclusive of those misses for imminent […]

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OGD

Revision 1 of Risk information in Promotional Materials and Ads Hits the Street

Say Goodbye to Ciprofloxacin 100mg Tablets!

Computer Problems Still Plague ANDA Approval Postings

Establishing a CCS Foundation for Cleaning Validation

Full FY 2023 ANDA Statistical Reports Arrived on November 1, 2023 – Let’s Take a Look!

EU Issues Communication Addressing Medicine/Drug Shortages

The Posting of ANDA Approval Actions Is Still a Problem – No Word on Time for a Fix

Drug-Device Combinations for Generic Drugs: A Good Session at AAM’s GRx+Biosims Conference

August 2023 Official OGD Statistics Released

More from AAM’s GRx-Biosims Conference: OGD Stats We Don’t Always See

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