On September 19, 2016, we posted a blog (here) announcing the FDA-sponsored competition to create an app that will connect victims of overdose with carriers of naloxone. Well, now we know the winner, and we also know that the competition attracted significant attention, as 150 teams registered for the competition and FDA received 45 submissions, […]
The recently issued Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance document (here) states that the FDA considers that the owner’s (those who engage the services of the contract facilities) Quality Unit responsibility includes approving or rejecting the contract facility’s product or service (be it for testing, processing, packing or holding). In addition, as […]
On Thanksgiving Eve, FDA issued the revised Quality Metrics Guidance. Is the revised document something for industry to be thankful for? Let’s break it down: Allowance for a phased-in, voluntary approach – This is something that many industry groups have been asking for, since the burden, as well as the complexity of collecting metrics from […]
Whether you are into tofurkey, real turkey, ham or whatever floats your boat, all of us at Lachman Consultants want to take a moment to wish you and yours a happy Thanksgiving. At this time of year, we all need to take stock (no pun intended) of our family and friends and realize that, while […]
FDA has announced that study data standards are required for clinical and nonclinical studies that are started after December 17, 2017. FDA notes that it may Refuse-to-File (RTF) NDAs and BLAs or Refuse-to-Receive ANDAs if the data does not conform to the standards outlined in the Guidance for Industry – Providing Regulatory Submissions In Electronic […]
Yesterday, FDA published two separate Federal Register Notices (here and here) announcing a Notice of Opportunity for Hearing (NOOH) for the withdrawal from marketing of two firms’ methylphenidate extended-release tablets. The Agency had previously expressed concerns regarding the Therapeutic Equivalence (TE) of these two products based on significantly higher reports of therapeutic failure later in […]
Based on multiple FDA inspections and observations over many years, both brand pharma and generic companies have learned how to be better prepared for an FDA inspection and what to expect from an FDA inspection. However, judging by the numerous Warning Letters that have been issued to Compounding Pharmacies in the last 2 years to […]
Most of us in the pharmaceutical industry have heard the phrase “targeted therapy”. Targeted therapies are drugs or other substances specifically designed to prevent cancer cells from dividing or destroying them directly, and are intended to target only cancer cells. While standard chemotherapy may affect all cells in the body (including healthy, non-cancerous tissue), targeted […]
Data integrity issues have cost pharmaceutical and healthcare companies millions of dollars in direct and indirect costs and led to potential risks to patient safety. Companies are in a frenzy responding to regulatory citations and preparing for inspections. The industry, mostly from “lessons learned”, generally understands the issues; and the regulatory expectations have been communicated […]
The FDA announced some additions (**) and revisions to titles (*) of Guidance documents it plans to release in 2016. We have posted on this list previously (here) (and here) and highlighted this blogger’s impression of some of those proposed Guidance documents. Well, FDA has published another revised list and here are the changes: Comparative […]
