ANDAs Archives - Page 15 of 52 - Lachman Consultant Services, Inc.

FDA Updates Draft Guidance on Required Notification of Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

By Bob Pollock Apr 05, 2023 ANDAs API BLA Compliance Drug Shortages FDA NDA

The FDA is updating the draft guidance entitled, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, that originally issued in March of 2020. As the drug shortage problem continues, this revised guidance (see here) is to better assist applicants and manufacturers in a process to provide […]

Apr

Update On Blog Post re: Solicitor General’s Skinny Label Amicus Curiae Brief

By Bob Pollock Apr 03, 2023 ANDAs FDA Generics Skinny Labeling

To follow up on last week’s blog (here). I came across the Amicus Curiae brief filed by the Solicitor General in the Teva v Glaxo case regarding the skinny label provisions of the Hatch-Waxman Act. I thought you would be interested in reading the brief for this important case so here it is! Enjoy the […]

Mar

Pattern obtained by superimposing black numbers on multicolored background. This is obtained by multiple colors paint watercolor technique on paper.

OGD Releases Official February 2023 Statistics -We Warned You!

By Bob Pollock Mar 29, 2023 ANDAs FDA Generics Metrics OGD Regulatory Affairs

When we looked at the mid-month February approvals back on February 22 (here), we projected that February might be a slim month for full approvals and we were right. OGD issued a total of 46 approval actions in February, the lowest total for a month thus far this fiscal year (FY). Of the 46 full […]

Mar

Face to Face Meetings at OGD – Get in Line and Get Ready!

By Bob Pollock Mar 27, 2023 ANDAs FDA Generics Meetings

That’s right! Get ready, get set, GO! Beginning March 27, 2023, OGD will start to accept requests for Face to Face (FTF) meetings again. However, according to the FDA announcement, FTF meetings will be limited to “pre-ANDA product development meetings and pre-submission meetings for which the applicant requests this in-person FTF meeting format.” Access may […]

Mar

Q1 & Q2 Differences Between RLD and Proposed Generic May Get Help from Legislation

By Bob Pollock Mar 15, 2023 ANDAs Formulation Generics Q1/Q2 Regulatory Affairs

Yesterday, “U.S. Senators Rand Paul (R-KY) and Maggie Hassan (D-NH), both members of the Health, Education, Labor, and Pensions Committee, reintroduced bipartisan legislation to streamline the approval process for generic medications, which are often significantly cheaper than their brand-name counterparts” says a release from Senator Paul’s office (here). If passed, the bill would direct the […]

Mar

January 2023 Official Statistics – and Yes, I Am a Bit Confused

By Bob Pollock Mar 06, 2023 ANDAs FDA Generics Statistics

When we reported the unofficial January approval actions in a previous blog post, there was some concern about how OGD would be reporting their approval and tentative approval actions on the daily report versus the Generic Drugs Program Monthly and Quarterly Activities Report (here). If you go back and read the January unofficial approval blog […]

Mar

REMS Bill – Is It Really the Answer?

By Bob Pollock Mar 03, 2023 ANDAs FDA Generics Hatch-Waxman Patents REMS

The Hill report (here) that “Sens. Maggie Hassan (D-N.H.) and Mike Braun (R-Ind.) on Wednesday reintroduced legislation intended to close a loophole that drug companies can exploit to block competition, including from lower-cost generic drugs.” The bill would permit FDA to approve a drug product for a generic immediately if all other approval requirements are […]

Feb

Join Lachman Consultants at Access!™ AAM Annual Meeting 2023

By Bob Pollock Feb 07, 2023 ANDAs Approvals FDA OGD Regulatory Affairs Statistics

Visit with Lachman Consultants in Griffin Foyer, Booth #4 at the AAM Annual Meeting. Lachman Consultants is a proud Business Exposition Sponsor of this yearly event that’s taking place at the JW Marriott Orlando Bonnet Creek Resort & Spa in Orlando Florida on February 13th-15th, 2023. Access!™ is where policymakers, influential speakers and industry leaders […]

Feb

January 2023 Unofficial Approval Actions and an Explanation!

By Bob Pollock Feb 06, 2023 ANDAs Approvals FDA OGD Regulatory Affairs Statistics

As we have noted in previous posts, the OGD has two types of approval actions for the various categories of approvals and tentative approvals. What the heck does that mean? Well, let’s take an example from this month’s approval actions. On January 24, 2023, the OGD approved one fentanyl application; however, that single application had […]

Jan

Petition Requests Removal of Generic Tasimelteon from the Market for Lack of Braille on Its Label

By Bob Pollock Jan 30, 2023 ANDAs FDA Generics Labeling Regulatory Affairs

This is something I have not come across in over fifty years in the pharmacy and pharmaceutical business! The issue is related to a drug product called Hetlioz (tasimelteon) capsules, marketed by Vanda. The product is indicated for non‑24‑hour sleep‑wake disorder (non‑24) and nighttime sleep disturbances in Smith‑Magenis Syndrome (SMS) in children and adults. The […]

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ANDAs

FDA Updates Draft Guidance on Required Notification of Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act

Update On Blog Post re: Solicitor General’s Skinny Label Amicus Curiae Brief

OGD Releases Official February 2023 Statistics -We Warned You!

Face to Face Meetings at OGD – Get in Line and Get Ready!

Q1 & Q2 Differences Between RLD and Proposed Generic May Get Help from Legislation

January 2023 Official Statistics – and Yes, I Am a Bit Confused

REMS Bill – Is It Really the Answer?

Join Lachman Consultants at Access!™ AAM Annual Meeting 2023

January 2023 Unofficial Approval Actions and an Explanation!

Petition Requests Removal of Generic Tasimelteon from the Market for Lack of Braille on Its Label

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