hiring

OMB Clarifies Hiring Freeze for FDA

A memo and its attachments was issued on February 6, 2017 to give various position classes, including pharmacist, consumer safety officers, microbiologists, chemists, medical officers, etc., which cover many of the FDA position classifications. Also, there is no freeze of the hiring of Commissioned Corps Officers of the United States Public Health Service.

Hopefully,

Frozen windows in winter time with frost decorations

Foreign Inspection Program Feels the Freeze

In the past week, the news media reported on President Trump’s meeting with some leaders of big pharma and among the themes discussed were the lowering of drug prices, cutting regulation, speeding up drug approvals and bringing jobs back to the U.S.  Previous postings have pointed out how the administration’s current freeze on Federal hiring may have the unintended effect of slowing drug approvals (see here).

FDA Badge

Who IS Going to Be the New Boss at FDA?

Well, not naming any names- I really won’t come out and say who my pick would be, but, depending on the administration’s pick, this is a pretty crucial decision for the Agency.  Here are some of the attributes I think would be important for the position:

  1. A knowledge of the FDA review and approval process
  2. A strong medical background
  3. A person that believes that science should rule the day
  4. Someone who is above the political fray
  5. A person that has both compassion and common sense
  6. Someone with an understanding of how the drug industry operated

Which of these attributes do I think is most important? 

stack of green books, compliance and related words

USP, BP, EP, JP – Which Can You Cite In Your Application?

FDA published an updated Manual of Policy and Procedure (MaPP), 5310.7 after a 10-year first edition and this one (in my opinion) really clears up one of the age-old questions – can I cite a foreign compendia as the basis for establishing a specification or test method in my application?  The answer is a resounding YES!if the method is as good as or better than the USP/NF provisions in a Monograph or in the General Chapters.

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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,

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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,
Tuna fish

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,

Gloved hand holding a vial with radioactive substance.

Good News/Not So Good News II? Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities

FDA issued the draft Guidance “Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities” (here) in late December 2016.

FDA reminds us that, under current law, radiopharmaceuticals that are compounded by entities that are not registered with FDA as outsourcing facilities (503B), and radiopharmaceuticals that are repackaged are subject to all applicable provisions for the production of drugs under the FD&C Act.

Gloved hand holding a vial with radioactive substance.

Good News/Not So Good News? Compounding and Repackaging of Radiopharmaceuticals

FDA issued two new Guidance for Industry Documents late in 2016: (1) Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities (here) and (2) Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities (here).  These represent the 25th and 26th  draft and/or final Guidances issued by FDA relating to pharmacy compounding.  

Mortar pharmacy

FDA Issues Three New Guidances for Compounding Pharmacies on December 28, 2016

FDA issued three new Guidance for Industry Documents late in 2016: (1) Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act (here) ; (2) Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities (here); and (3) Compounding and Repackaging of Radiopharmaceuticals by Outsourcing facilities (here).

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Happy Holidays from All of Us at Lachman

I can’t believe another year has slipped away already. Seems like yesterday I was writing the holiday blog for 2015 and here we are again.  This year brought us the renegotiations of all of the UFAs, the largest number of Generic Drug approval since the new counting system went into effect (for those of you who don’t know what I am talking about – you are too young,

Quit smoking word written with broken cigarette concept for quitting smoking

Boxed Warning for Serious Mental Health Issues Removed from Chantix and Zyban Labeling

Back in April 2016, we posted a blog regarding the potential for the FDA to remove the Black Box warning on two products indicated to help patients stop smoking based on a large clinical study that the FDA required.  At that time when the studies were submitted, the Agency indicated it would review the results and make a final determination. 

Mortar pharmacy

FDA Publishes List of First Bulk Drug Substances for 503A Compounding

The FDA issued a Proposed Rule (here) that announced the first additional 6 bulk drug substances for inclusion on the listing of bulk drug substances acceptable for pharmacy compounding, although they are neither the subject of an applicable United States Pharmacopoeia (USP), nor National Formulary (NF) monograph, nor components of FDA-approved drugs.

quality concept handwritten on blackboard

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,

Businessman and businesswoman working in office

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,