20
Apr
Capsules in mortar

Emergency Preparedness – FDA Continues Active Oversight in the Compounding Space

FDA has been discussing using temporary enforcement discretion in two April 2020 Guidance for Industry documents for sterile compounding during the Covid-19 crisis: “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID-19 Public Health Emergency (here)” and “Temporary Policy Regarding Non Standard PPE Practices for Sterile Compounding by […]

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03
Apr

COVID-19 Devices in the Fast Lane – Help is Here!

Lachman Consultants recognizes the urgency of supporting the COVID-19 response efforts.  Companies may be adding additional personnel or expanding manufacturing resources to aid in producing life-saving medical equipment and supplies.  While COVID-19 is requiring non-essential personnel to stay home and stay safe, these teams are at the forefront.  We want to assure you that Lachman […]

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30
Mar

FDA Continues to Expedite Diagnostic Tests to Detect COVID 19

The FDA announcement (here) of its activities involved in expediting diagnostic tests for the Corona Virus (COVID 19) explains the actions that FDA has taken in response to this public health emergency. “The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the […]

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11
Feb
A man is completing the construction of a bridge. Build bridges, make connections and useful contacts. Improving and developing a business. New innovative solutions, growth and prosperity

FDA Provides Valuable Guidance on Bridge-Building for Combination Products

Three of FDA’s Centers (CDER, CBER, and CDRH) recently published a combined draft guidance for Industry entitled Bridging for Drug-Device and Biologic-Device Combination Products  (here).  This draft guidance provides the FDA’s current thinking on what manufacturers should consider when they wish to bridge the data from one such combination product to another combination product during […]

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22
Oct
Document Issued for Manufacturing Facility Information Image

Q&A Document Issued for Manufacturing Facility Information

The FDA released a final Q&A document titled “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER: Questions and Answers” that provides answers to some of the most frequently asked and problematic questions raised by incomplete manufacturing, testing, packaging, etc. The document provides specific guidance on what, where, and how to list such […]

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