compliance360

Compliance 360 – An 8-part podcast survival guide to US FDA enforcement and compliance

Join former FDA Investigations Branch Director Ricki Chase –now with Lachman Consultants – as she draws on her 16 years of agency experience to bring you the latest insights into FDA inspections, interactions and expectations.

PODCAST LINEUP

February 6
Handling Difficult US FDA Investigators

February 13
Getting The Most Out Of Your Inspection:
Close-Out Meetings

February 20
Building Trust With US FDA:
Can It Be Done?

Business analysis, calculation of the budget in the design of information related to business

Hey, Wait a Minute Here! Are the UFAs in Danger?

Just as the various User Fee Acts (UFA) go to congress for mark-up and reauthorization, a proposed administration budget contains a suggested doubling of fees charged for medical product reviews.  Am I seeing this correctly?  Industry and FDA have worked tirelessly over the last year and a half to get the various User Fee programs negotiated for reauthorization and at the 11th hour,

view of the Earth from space, blue planet and deep black space

Ozone-Depleting Final Rule Escapes Freeze

In a Federal Register Notice published today, FDA announced that the direct final rule on “Use of Ozone Depleting Substances” published on October 26, 2016 is “excluded from the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled ‘Regulatory Freeze Pending Review,’ this action confirms the effective date of February 23,

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.

concept weak management diagram planning work flow busy chaotic concept

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,

Cropped image of businesswoman writing on checklist

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).

Handdrawn lettering happy holiday. design for holiday greeting cards and invitations of the Merry Christmas and Happy New Year and seasonal holidays. vector

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,