06
Dec

Reconsideration: Non-Sterile Drug Manufacture – Don’t Let It Bug You!

The bulk of microbiology attention in the drug manufacturing world is laser focused on sterile drug products and the myriad steps needed to aseptically manufacture them. That is certainly with good reason as those drug products carry the highest patient risk should there be microbial contamination. One aseptic manufacturing misstep and the consequences could be […]

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05
Dec
Congress Questioning Delayed FDA Action on Phenylephrine - Lachman blog image

Congress Questioning Delayed FDA Action on Phenylephrine – What About Impact on Other Decongestants?

In an article published in Fierce Pharma today (here), Kevin Dunleavy pointed to a congressional letter (here), penned by Congresswoman Lisa McClain, Chairwoman, Subcommittee on Health Care and Financial Services, that questions the long lag time for the FDA and its advisory committee to come to the conclusion that phenylephrine, as an oral decongestant, does […]

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22
Nov

Establishing a CCS Foundation for Cleaning Validation 

Bring up the recently updated and finalized EU Annex 1 – Manufacture of Sterile Medicinal Drug Products (here) in polite pharmaceutical water cooler conversation and a frequent topic that comes up is the Contamination Control Strategy (CCS) language.  Buzzwords abound for a “holistic”, “global”, or “wholesale” CCS to be incorporated into all elements of aseptic […]

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07
Nov
Orphan Drug Preemptive Challenge Strikes at One Aspect of the Orphan Drug Exclusivity Decision Making

Orphan Drug Preemptive Challenge Strikes at One Aspect of the Orphan Drug Exclusivity Decision Making

Sidley Austin LLP filed a petition (here) requesting that FDA not grant orphan drug exclusivity to a ready-to-use version oral solution of vigabatrin. There are currently two versions of vigabatrin already approved with a number of generics available. The original approved NDA products (tablet and power for reconstitution) were granted orphan drug exclusivity (ODE), the […]

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30
Oct

EU Issues Communication Addressing Medicine/Drug Shortages 

The EU has continued its advancement of initiatives and intentions to combat the drug shortage problem.  The latest communication is titled “Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions: Addressing medicine shortages in the EU” (here).  This is a deep dive […]

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24
Oct

Dissemination of Articles and Study Results, New Revised Q&A Draft Guide May Provide Better Direction

Yesterday, the FDA issued a draft guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers” (here). If you can get that out of your mouth without taking a breath, I think you must be a free diver. The issue of disseminating information […]

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16
Oct
Methanol_Molecule_LachmanBlog

FDA Issues New Guidance for Methanol Testing in Pharmaceutical Alcohols

On the heels of additional reports of methanol poisoning from ingestion of hand sanitizers, the FDA issued a new final guidance titled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol (here) for immediate implementation. The guidance applies to the use of pharmaceutical alcohols (PAs) (ethanol and isopropyl alcohol) by pharmaceutical manufacturers, outsourcing […]

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08
Oct

Signs of Progress on the Nitrosamine Front – Notes from the Nitrosamines Session at GRx+Biosims 2023 

The session on nitrosamine impurities was held during the final breakout session on Wednesday morning during the final day of the conference. This session had the largest panel by far of those assembled on any topic presented at the conference, with 15 total panelists including the session moderator!  It was even more difficult than usual […]

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