Safety Archives - Lachman Consultant Services, Inc.

Just When you Thought it Was Safe to Come out of the Compounding Hood: Apparent Dearthof Evidence for the Effectiveness and Safety of Compounded Bioidentical Hormone Therapy

By Roy Sturgeon, PhD. Jul 08, 2020 Compliance Compounders Compounding Efficacy Safety

In late 2018, FDA entered a contract with the National Academies of Sciences, Engineering, and Medicine (the National Academies) to examine the clinical utility (effectiveness), safety and uses of compounded bioidentical hormone therapy (cBHT). A high-level committee was formed and examined in detail the clinical utility of cBHT drug preparations, especially those containing estradiol, estrone, […]

Jun

Close up of female student study using handbooks writing notes

REMS – Revision 2 Adds Updates to Previous Two Versions

By Bob Pollock Jun 29, 2020 ANDAs BLA Generics NDA New Drugs Regulatory Affairs REMS Safety

The FDA released an updated version of its Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry as Revision 2. Originally issued in 2015 (here) and updated again in 2019, the June 2020 version contains much the same information but provides updates as to timetables, additional categories of PAS, CBE, and CBE 30 […]

Feb

A bearded viking brandishing a steel broadsword

Sometimes you get what you pay for; FDA joins forces with India to halt illicit drug sales

By Michelle Ryder Feb 19, 2020 Compliance Enforcement FDA Generics Public health Quality Safety

The United States Food and Drug Administration and the Indian Government join forces in “Operation Broadsword”. No, it’s not a trailer for an action thriller, it’s a serious collaboration between two governmental entities to limit the import and sale of illicit drugs to consumers, detailed in FDA’s news release on February 18, 2020 (here). The […]

Feb

What Is It? – Identity Testing Re-visited

By James Davidson, Ph.D. Feb 13, 2020 Analytical Methods ANDAs BLA Chemistry CMC Compliance Excipients FDA Generics Inactive ingredients IND Manufacturing NDA New Drugs OGD Quality Regulatory Affairs Safety

In earlier blogs, we have written about specific technical items related to identity testing. However, a review of Warning Letters published on the US FDA website for the months of December 2019 and January 2020, revealed three Warning Letters citing instances of failures to perform identity testing of active pharmaceutical ingredients prior to the manufacturing […]

Feb

Researcher adding liquid from test tube with fire symbol, warning sign, danger

The “Unwelcome Guest” Spares Metformin

By Pete Manger Feb 05, 2020 Analytical Methods CMC Compliance FDA Manufacturing Quality Regulatory Affairs Safety

Recently, FDA has posted (here) that Metformin, from several sources, tested by FDA showed that the levels of N-nitroso-dimethylamine (NDMA) in the drug are below the levels of detection (here). Great news! NDMA belongs to the nitrosamine family, and is one of the well-known animal carcinogens and a suspected human carcinogen. The nitrosamines, including NDMA, […]

Jan

FDA Safety Communication: Clozaril Bowel Back-up Could Be Fatal

By Bob Pollock Jan 29, 2020 FDA Safety Warnings

In a very recent safety communication, due to an increase in serious bowel issues from severe constipation to complete bowel obstruction that have been reported for Clozaril, the FDA is alerting the public and health care providers of this new information. The communication notes that this adverse event can, in some patients, be serious and […]

Jan

FDA Evaluating Diet Drug Risks for Increase in Cancer Rates

By Bob Pollock Jan 14, 2020 FDA NDA Regulatory Affairs Safety

In a January 14, 2020 Drug Safety Communication (here), FDA discusses an alert to patients taking the weight loss drugs Belviq or Belviq XR (lorcaserin) of a potential increase in the risk of cancer. The NDA drug products were approved on July 27, 2012 (immediate-release) and July 15, 2016 (extended-release version), respectively. The Agency notes […]

Nov

Hope at This Time of Giving Thanks

By Bob Pollock Nov 26, 2019 505(b)(2) Abuse deterrent Accelerated Approval Advertising Analytical Methods ANDAs Approvals Bioanalytical Bioequivalence Biologics Biosimilars BLA Brand Name Drugs Bulk Drugs List CBER CDER Chemistry Clinical CMC Combination Products Complex Generics Compliance Compounders Compounding Controlled correspondence CVM Data Integrity DEA Device Dietary Supplements Drug Pricing Drug Shortages eCTD Emerging Technology Enforcement Exclusivity FDA FDA First Generics Foods GDUFA Fees Generics Guidance Homeopathic Drugs ICH Imports International Label Changes Labeling Laboratories Manufacturing Medical Devices NDA New Drugs OGD Opioids OTC Petitions PMA Post Approval projectsnowflake Receipts Regulatory Affairs Safety Science & Technology Shortages Training Uncategorized User Fees Validation

Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]

Oct

Nitrosamines – Expensive Witch Hunt or Very Broad Safety Concern?

By Ron George, Ph.D. Oct 29, 2019 ANDAs FDA NDA Regulatory Affairs Safety Science & Technology

I have recently touched upon the subject of nitrosamines in drug products as part of a blog on Extraneous Peaks (here). The concern about nitrosamines in drug products continues to grow, and it will be a significant challenge for the regulators and pharmaceutical industry to establish meaningful policies and procedures to ensure there are no […]

Jul

African American Woman Tests Blood Sugar

Powdered Glucagon Approved for Emergency Use in Hypoglycemia

By Bob Pollock Jul 29, 2019 FDA NDA Regulatory Affairs Safety

In announcing the July 24th approval of Baqsimi (glucagon powder for nasal administration) (here) FDA notes that it is the first form of glucagon that can be administered without injection. The product is to be used by a caregiver or we assume someone on the street if the patient is unconscious. The product is a […]

Safety

Just When you Thought it Was Safe to Come out of the Compounding Hood: Apparent Dearthof Evidence for the Effectiveness and Safety of Compounded Bioidentical Hormone Therapy

REMS – Revision 2 Adds Updates to Previous Two Versions

Sometimes you get what you pay for; FDA joins forces with India to halt illicit drug sales

What Is It? – Identity Testing Re-visited

The “Unwelcome Guest” Spares Metformin

FDA Safety Communication: Clozaril Bowel Back-up Could Be Fatal

FDA Evaluating Diet Drug Risks for Increase in Cancer Rates

Hope at This Time of Giving Thanks

Nitrosamines – Expensive Witch Hunt or Very Broad Safety Concern?

Powdered Glucagon Approved for Emergency Use in Hypoglycemia

Subscribe to our Blog

Categories

Archives

Have you tried?

Get the answers and guidance to your most
pressing questions faster than ever before.

Safety

Subscribe to our Blog

Categories

Archives

Have you tried?

Get the answers and guidance to your most pressing questions faster than ever before.

Get the answers and guidance to your most
pressing questions faster than ever before.