No New Regulations – No New Hires – Will the Administration’s Actions Impact the Drug Approval Process?

Donald Trump signed an Executive Order freezing government hiring, except for the military, national security, or public safety personnel, and issued a memorandum placing a moratorium on any new regulations or Guidance. In addition, it is reported that the memorandum noted that if new regulations have been sent to the Federal Register, but yet unpublished,

FDA 2017 List of 101 Guidances – How Many Apply to Compounding Pharmacies and Are You Current and in Compliance???

For 503A and 503B compounding pharmacies, how do you protect your business from heavy-handed interventions from State and Federal Regulators? Can you affirmatively respond to the following questions?

  • Do you know the Federal and State laws you are required to follow?
  • Do you have the right enabling documentation (procedures, policies,

Fish is Good for You, But Apparently, Not Too Much!

While we usually cover drug- and device-related topics in this blog, something came swimming our way on an unrelated topic that I thought might pique your interest.  I always thought that eating fish over red meat was a healthy choice.  Well, that is still true, as long as you don’t eat too much.  In a Federal Register (FR) notice (here) issued today,

An Injection of Advice on Generic Drug-Device Combination Products from FDA

In another generic drug Guidance issued in the beginning of the year, OGD Guidance tsunami, FDA has provided advice on how to decide what might be necessary to gain approval of an ANDA, where there is a drug-device patient interface.  FDA notes throughout the Guidance that each ANDA will be evaluated on a case-by-case basis and the deciding factor will be that (as first explained in an old petition response to King Pharmaceuticals) “[i]n general,

Botanical Drug Development Guidance Undergoes Its First Revision

First issued in draft in 2004 and then revised as a draft in 2015, Revision 1 of the Guidance document “Botanical Drug Development” issues in final form.

The Guidance reflects current Agency thinking on the drug development process for new drugs (NDAs), investigational new drug applications (INDs) to support NDAs, and a discussion of the appropriate mechanism for seeking inclusion of botanical products in the over-the-counter (OTC) monograph system.

More Bioequivalence Guidance Documents Issued by OGD

The Office of Generic Drugs (OGD) has been busy in the bioequivalence arena as evidenced by its issuing of 31 new recommendations and revising 17 previously issued recommendations.  The list of new and revised recommendations can be found here.

As always, there are some specific recommendations that are of note while others are standard bioequivalence recommendations. 

Quality Agreements a “Must Have” for Use of CMO

 

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,

Happy Holidays – FDA Issues Highly Anticipated Revised Quality Metrics Guidance

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 large,

This Turkey Wants to Wish You a Happy Thanksgiving

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 we all have difficult jobs,

Upcoming eCTD Date for Technical Rejection Criteria for Study Data

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 Format — Standardized Study Data and to comply with the outline in this notice which can be found here.

Notice of Opportunity for Hearing Issued for Two Methylphenidate Generics to Concerta

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 the day than the reference listed drug product (and/or authorized generic). 

Compounding Pharmacies – Still in the Cross Hairs

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 503A (43 total) and 503B (37 total),

Getting a CRISPR View – Genetic Editing: Medical Frontier

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 therapy uses drugs or other specially created substances (e.g.,

Data Governance – Establishing a Path Forward to Assure Data Integrity

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 through a number of recent guidances (drafts,