Bob Pollock, Author at Lachman Consultant Services, Inc.

Lachman Consultants Named “Top-Ten Medical Device Consulting Company” by Med-Tech Outlook

By Bob Pollock Nov 18, 2020 News

(Westbury, NY— November 2020) Lachman Consultant Services, Inc. (Lachman Consultants), a provider of compliance, regulatory, and technical consulting services to the global pharmaceutical and related industries, was recently named a “Top-Ten Medical Device Consulting Company” by highly-regarded, industry publication MedTech Outlook. In making the announcement in its September issue, the monthly periodical outlined that its […]

Aug

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APPROVAL AND TENTATIVE APPROVAL ACTIONS NUMBER FOR ANDAS JULY 2020

By Bob Pollock Aug 05, 2020 ANDAs Approvals FDA Generics Regulatory Affairs

As of August 5, 2020, the FDA had posted 69 full approval actions and 9 tentative approval actions for ANDAs for July 2020. The total of 78 approval actions for the month of July fall short of the 87 Approval actions in June but appears to be consistent with the last four month’s totals. Some […]

Aug

Rebecca (Becky) Welton, new Senior Associate in the Regulatory Practice at Lachman Consultants

By Bob Pollock Aug 03, 2020 News

We are pleased to announce that Rebecca Welton has accepted the position of Senior Associate in the Regulatory Practice at Lachman Consultants, effective August 3, 2020. Ms. Welton is an experienced Science, Operations and Regulatory leader with 25+ years in the pharmaceutical industry, holding positions of escalating accountabilities in chemistry, formulation, management, pilot plant, and […]

Jul

Could July Be Another Good Month for OGD Approvals?

By Bob Pollock Jul 28, 2020 ANDAs Approval Actions FDA Generics

With five reporting days left in the month, the OGD reporting approval actions captured in the Daily Approvals list (here) and the All Approvals list (here) totaled fifty-eight full-approval actions and only four tentative-approval actions. This gives the OGD a chance to break the total approvals total for any month in FY 2020 if it […]

May

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ERRATA-OGD Updates March 2020 Statistics

By Bob Pollock May 13, 2020 ANDAs FDA Generics Regulatory Affairs Statistics

The Office of Generic Drugs updated its March 2020 statistics today (here) with few surprises. As they say on American Idol, when giving the results, “dim the lights and here we go.” The OGD again refused to receive only three ANDAs in March and all three were for standard review ANDAs. There were sixty-three ANDAs […]

May

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FDA Grants EUA for Remdesivir

By Bob Pollock May 01, 2020 COVID-19 Drugs FDA

No, this is not an approval, but it is an emergency use authorization to use the antiviral Remdesivir for COVID 19 patients. The FDA issued this EUA on Friday, in record time, after positive results of the study involving Gilead’s drug. The EUA will remain in effect until the COVID 19 public health emergency is […]

Apr

Tests for Antibodies to COVID 19 Virus; Can You Count on the Results?

By Bob Pollock Apr 28, 2020 Compliance COVID-19 Device FDA Science & Technology

In a rush to get serology tests out for public testing, it appears that the FDA hopped, skipped, and jumped a bit too far by not first requiring at a minimum, review of the tests and the validation of the tests through an Emergency Use Authorization (EUA) prior to them going on the market. There […]

Apr

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March 2020 Approval Actions, CRLs and Receipts and Update on Feb Metrics

By Bob Pollock Apr 16, 2020 ANDAs FDA Generics Metrics

Today OGD provided partial information for the typical first reported March Metrics and updated its February 2020 metrics. Let’s start with the new March data. OGD reports 60 full approval actions and 17 tentative approval actions for a total of 77 approval actions for original applications in March, which is the highest number of total […]

Apr

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How Do Bad Facts Become Fake News and Possibly Worse?

By Bob Pollock Apr 07, 2020 BLA Compliance FDA Generic Drugs NDA Science & Technology

Oftentimes, we hear startling statistics that make us shiver and can cause a knee jerk reaction. Much has been written about the quantity of drugs that come from overseas, and the push for moving manufacturing of active pharmaceutical ingredients (API) and finished dosage forms (FDF) back into the U.S. While bringing jobs back to the […]

Apr

Let’s Face It! Protective Masks Have Revised Enforcement Policy Issued by CDRH

By Bob Pollock Apr 06, 2020 CDRH COVID-19 Face Masks FDA Regulatory Affairs

The Center for Devices and Radiological Health (CDRH) issued a revised guidance describing its policy on enforcement strategy for public personal use and filtered healthcare professional face masks titled Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (here). The CDRH says the relaxed policy will remain in effect […]

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