Sleep Driving, Sleep Walking, and Other Misadventures Prompt Black Box Warning

FDA notes that it “identified 62 cases of complex sleep behaviors that resulted in serious injuries or death after taking insomnia medicines eszopiclone, zaleplon, or zolpidem reported in the FDA Adverse Event Reporting System (FAERS) database between December 16, 1992, and February 27, 2018, and four additional cases reported in the medical literature1-5 between December 16,

Have You Visited the Newly Designed FDA Website?

Well, for us old folks, change is always something that makes us queasy.  The newly-designed FDA website stirred those feeling all over again as we try to navigate the new links and find the information that was once at our fingertips (or at least in our bookmarks).  There were some wrong turns and some dead links along the way,

April Has 82 Approval Actions Coming Down the Stretch

With four reporting days remaining in April, the Office of Generic Drugs has issued full approval actions on sixty-nine ANDAs and tentative approval actions on thirteen ANDAs for a total of eighty-two approval actions.  We remind our readers of the potential difference from actual individual ANDA approvals or actual individual ANDA tentative approvals based on a new footnote found at the bottom of the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance first appearing sometime in April 2019 (here) and further discussed in our blog post of April 16th (here).

Extension of Doxycyline Expiration Dating for National Stockpiles

Back in 2016, FDA indicated that it was planning to issue a guidance document to explain to firms how to extend expiration dating for doxycycline tablets and capsules held in national stockpiles (here) .  Doxycycline is stored in national stockpiles for treatment of post-exposure prophylaxis (PEP) or treatment of inhalational anthrax in the event of an anthrax emergency. 

FDA Announces Enforcement Discretion for Postmarketing Safety Reporting of Combination Products

 

In an immediately effective guidance document entitled Compliance Policy for Combination Product Postmarketing Safety Reporting (here), the FDA is announcing that it will exercise enforcement discretion for certain safety reporting requirements outlined in the Combination Product Postmarketing Safety Reporting Final Rule issued on December 20, 2016 (81 FR 92603) and codified in 21 CFR Part 4,

New Footnote Raises Questions About Approval Numbers

As I was reviewing the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance (here) as I do a few times a month, I came across a new footnote to the report.  It reads:

++++ = FY19 Approval and Tentative Approval counts were updated in April 2019 to better reflect program output by capturing all approval actions on original applications,

Patiotic cowboy boots

Consumer Antiseptic Rubs Final Rule – or Is It?

Publishing tomorrow, the FDA will announce that 28 ingredients that were considered in the June 30, 2016 proposed rule were given the boot while further consideration of three ingredients (benzalkonium chloride, alcohol (also referred to as ethanol or ethyl alcohol), and isopropyl alcohol) were deferred until the firms had more time to conduct appropriate studies and the Agency has time to review the additional information to be submitted. 

Back view business woman raising hand for asking speaker for question and answer concept in meeting room for seminar

OBSERVATIONS AND INSIGHTS FROM ISPE 2019

As always, Lachman Consultants looks to provide excellence in all phases of serving our clients’ needs, so we paid close attention to the various speakers, panels and general goings-on at the 2019 ISPE Europe meeting to take the pulse of the industry.  We also spoke to many of the show’s attendees, and the takeaways from our many observations and conversations covered a variety of topics.  

March Official Approval Numbers and Receipts Are in – We Were Close!

March 2019 actually saw 89 full approvals and 17 tentative approvals for 106 approval actions (our predictions were off by one).  This is another good month for ANDA approvals, but it is also a month that saw the largest number of ANDA submission for FY 2019 at 118.  We believe this corresponds to the end of the fiscal year for India,

Bioanalytical Workshop Generates Question on FDA vs. ICH Guidance

The 13th annual WRIB (Workshop on Recent Issues of Bioanalysis) was held in New Orleans, LA this week and is wrapping up today.  The workshop was well represented by regulators and industry (both from Pharma and CROs), with numerous discussions and topics for the bioanalysis of small and large molecules.  Presentations covered the full spectrum of bioanalysis from recently issued guidance documents (both draft and final),

Gottlieb’s Parting Message on Compounding – Priorities for 2019

As the FDA and industry prepare for Dr. Gottlieb’s departure from the FDA tomorrow, he and Deputy Commissioner Anna Abram issued a statement (here) on the FDA’s 2019 priorities to improve the quality of compounded drugs.  As the statement notes, compounded drug products are not FDA-approved and, thus, can pose a serious threat to the public if not prepared properly. 

Accomplished Global Pharma Executive Mary Oates Joins Lachman Consultants, Inc. as VP of Compliance Services

(Westbury, NY – April 2, 2019) Fran Zipp, President and CEO of Lachman Consultants, Inc. a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, today announced that Mary Oates has joined the firm as Vice President of Compliance Services. In her role, Oates will lead the expert team that comprises Lachman’s Compliance Practice Group,

FDA Blasts Shots Over the Bow to Four Homeopathic Firms for CGMP Violations

 

In the not-too-distant past (April 2015), the FDA held a public hearing on potential changes to the enforcement policies and the regulatory approach associated with the marketing of homeopathic drug products.  The FDA indicated that it has not had a comprehensive review of the enforcement policies related to these products to reflect changes in the homeopathic market in over twenty-five years (twenty‑seven years now).