Drug Shortages Archives - 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FDA Updates Draft Guidance on Required Notification of Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the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The FDA is updating the draft guidance entitled, Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act, that originally issued in March of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 […]

Feb

As Ibuprofen Shortage Rages On, FDA Revises Recently Issued Guidance

By Bob Pollock Feb 09, 2023 Compliance Drug Shortages FDA Regulatory Affairs

On February 9, 2023, the FDA issued a revised guidance (here) on the compounding of Ibuprofen oral suspension products for outsourcing facilities. We previously posted about the original document (here) and discussed the basic factors that caused the Agency to issue the guidance without public comment to meet the needs of a drug shortage that […]

Jul

Expiration Date Extensions for Critical Drugs on the Shortage List

By Bob Pollock Jul 01, 2021 Compliance Drug Shortages FDA Regulatory Affairs

FDA has worked with companies to support expiration date extensions for “critical” drugs on the FDA’s drug shortage list. The current list (here) contains 343 entries Most products have had their expiration dates extended by one year from the labeled expiration date. The list provides information to providers to verify that the firm had submitted […]

Mar

Coronavirus Readiness

By Fran Zipp Mar 13, 2020 ANDAs CBER CDER CDRH Drug Shortages Importation International New Drugs News OGD OTC Public health Quality Shortages Uncategorized

As the impact of the Coronavirus (COVID-19) is being felt throughout the United States and around the world, Lachman Consultants is reaching out to inform our valued clients and partners regarding the actions taken by our organization. Our continuing goal is to best safeguard the health and safety of our people, those within your […]

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

Drug Shortages Report Provides Look Forward

By Bob Pollock Oct 30, 2019 BLA Drug Shortages FDA Generics NDA Regulatory Affairs

Drug shortages have been in the headlines for years but getting them under control has proved to be a complex, multifaceted problem. Reports of critical shortages for chemotherapeutic agents, saline solutions, other injectables, and oral medications have lead healthcare providers oft times to seek other options for therapy. There has even been one firm created […]

Drug Shortages

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

As Ibuprofen Shortage Rages On, FDA Revises Recently Issued Guidance

Expiration Date Extensions for Critical Drugs on the Shortage List

Coronavirus Readiness

Hope at This Time of Giving Thanks

Drug Shortages Report Provides Look Forward

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