The FDA’s operations are uniquely positioned during a shutdown due to its reliance on User Fee Act carryover funds. This funding source allows a portion of the agency to continue functioning even without appropriated congressional funds.

How FDA Staffing is Affected by the Shutdown

At the onset of the shutdown, the FDA categorised its staff based on funding and mission-critical needs.

• 14% of FDA staff are furloughed.
• 86% of FDA staff continue to work, with: 66% supported by User Fee Act carryover funds.
• 19% exempted due to work on activities addressing “imminent threats to human life.

It is important to note that staff not covered by user fees may be working without pay, which can gradually impact overall operational efficiency over time, potentially causing indirect delays in FDA review timelines.

What the FDA Shutdown Means for Your Submissions

The most immediate impact of the government shutdown on drug approvals is the clear division between ongoing and paused activities.

Activities That Continue:

Review of pending drug, biologic, and medical device applications already submitted and supported by user fees.

Activities That are Paused:

• The FDA will not accept any new applications that require a fee. This includes:
  • New Drug Applications (NDAs)
  • Biologics License Applications (BLAs)
  • Biosimilar Applications

IND Activity and Clinical Development

While certain Investigational New Drug (IND)-related activities may continue, the FDA’s ability to manage these reviews efficiently could be hindered by staff shortages and reallocation of personnel to urgent public health priorities.

Companies may also face delays in scheduling or holding meetings with the FDA Agency, particularly for programs not deemed time sensitive.

Broader Uncertainties, Implications and Strategic Considerations

An additional unknown is whether ongoing political rhetoric — including threats of further federal workforce reductions — might affect FDA staffing in the weeks ahead. Any such action could further disrupt regulatory timelines and deepen uncertainty for ongoing development programs.

Conclusion

For the biotech and pharmaceutical industry, the 2025 U.S. government shutdown underscores the vulnerability of regulatory processes to political gridlock. While User Fee Act funding provides temporary buffer for key FDA activities, the inability to submit new applications and the strain on Agency resources could slow innovation and delay critical therapies from reaching patients.

Companies should maintain proactive communication with their regulatory affairs teams, track FDA updates, and prepare contingency plans for potential delays in IND interactions and submission timelines.

The next few weeks will be pivotal in determining whether this disruption remains a short-term inconvenience — or evolves into a significant drag on U.S. biopharmaceutical progress.

Stay Informed with Enimera RegsPlus

To stay ahead of regulatory developments and understand how FDA policy shifts may affect your IND and product development strategies, visit Enimera RegsPlus who has Regulatory FDA experience.

Our regulatory strategy team tracks real-time FDA activity and provides actionable insights tailored to the biotech and pharma sectors.

Contact Enimera RegsPlus for a Regulatory Strategic Consultation.

Stay informed. Stay compliant. Stay ahead.

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Medicinal cannabis as a traditional therapeutic – i.e. backed by the typical platform of quality, safety and efficacy data and accompanied by prescribing information – is still relatively new.  So if you enjoy Regulatory puzzles, you are in the right space.

Let’s look at four regulators… At the time of writing…

• In Australia, the Therapeutic Goods Administration has approved one registered medicinal cannabis product, though has approved over 7,700 applications to access ‘unapproved’ medicinal cannabis under the Special Access Scheme (Category B). Five clinical guidance documents are available (co-ordinated by the Department of Health), and specific regulatory requirements include Therapeutic Goods Order 93 which outlines minimum quality standards. In addition to the federal oversight by the TGA, state and territory-level regulation is also in place.
• In New Zealand, Medsafe has provided consent to one medicinal cannabis product. Ministerial approval, delegated to Medsafe, is required for cannabis products not approved via the new medicine consent process. The New Zealand Ministry of Health shares clinical guidance for use of cannabis-based products, guidance which was developed with external consultation.
• Health Canada regulates prescription products and medical devices containing cannabis or cannabis-derived products under the existing drug review process.  One prescription medicine has been authorised. Additionally, individuals are able to access medicinal cannabis via other means (directly from a federally licensed seller, producing a limited amount of cannabis for their own medicinal purpose, designating someone to produce it for them).
• To date, the US FDA approved one prescription medicinal cannabis product. The Expanded Access pathway and Right to Try avenue may provide an option for seriously-ill patients seeking to access unapproved medicinal cannabis products. Additionally, medicinal and/or recreational use of cannabis is now allowed in some states.  A public hearing was recently held by the US FDA in relation to medicinal cannabis, with a variety of stakeholders represented, including acadaemia, health care professionals, patients, government, and other stakeholders with an interest in this area. A docket for public comment remains open until 02 July, 2019.

So, how do you begin your Regulatory Strategy for Medicinal Cannabis?  Try answering the following five questions…

… and remember to fall back on some basic Regulatory Strategy principles (links to my Regulatory Strategy articles are provided below).

FIVE QUESTIONS TO HELP YOU BEGIN YOUR MEDICINAL CANNABIS REGULATORY STRATEGY…

• What is the political state of play with regards of legalisation of cannabis use in your region(s) of interest? Though they evolve, regulations can be a point-in-time reflection of the broader landscape.
• What is the compositional profile of the medicinal cannabis product – what proportion comprises psychoactive components (such as tetrahydrocannabinol, or THC) versus non-psychoactive components (such as cannabidiol, also known as CBD)?
• What is the intended indication(s) and what is the current therapeutic regime in that space?
• What are the expectations of your target federal and state (if applicable) regulators? Don’t forget to undertake a targeted on-line search for guidance documents and must-have compliance requirements.
• What regulatory pathways might your target Regulator(s) offer, and how closely do they follow the processes and requirements for non-medicinal cannabis therapeutics?

Contact Mary for a complimentary Regulatory Strategy starter tip discussion or Regulatory Strategy assessment.

The post Medicinal cannabis – How to begin your Regulatory Strategy appeared first on Enimera RegsPlus.

If you work with OTC or Prescription Medicines, I’m sure you are aware of the TGA mandatory reporting scheme for medicine shortages in effect from January 2019 https://apps.tga.gov.au/prod/MSI/search.

Whilst the TGA did have some powers to publish notifications of shortages under the voluntary reporting scheme initiated in 2014, the scheme overall was considered to be of limited value to the healthcare community as the information it housed was limited and often not timely.

It is voluntary no more for all prescription medicines and for some OTCs. If in doubt about the legislative basis for this new reporting scheme, it might be wise to take a close look at the two key legal documents and consult your Legal team.

1.    The updated Therapeutic Goods Act (2018 Measures No.1) – Section 30 EH, to be precise –  which, amongst other things, defines a shortage and specifies the mandatory reporting times for the critical and medium/low impact shortages.

2.    The legal instrument Therapeutic Goods (Reportable Medicines) Determination 2018, which specifies the 11 OTC ingredients which qualify under this mandatory scheme.

What does this mean for you, a Regulatory Affairs leader with accountability for reporting medicine shortages? Be prepared. Review your organisation’s readiness and ensure processes enable cross-functional engagement and escalation measures where appropriate.

Above all, no matter how challenging it may be to keep up with supply chain oscillations, be encouraged by the importance of this medicine shortage reporting scheme to patients.

A few more tips for you…

FIVE QUESTIONS TO CONSIDER IN DEVELOPING AN EFFICIENT APPROACH TO REPORTING MEDICINE SHORTAGES

• Am I considering this from the healthcare professional or patient perspective?
• Am I championing the scheme’s importance throughout my organisation?
• Which products are likely to need closer management and the formation of cross-functional rapid response teams?
• Are my team members adequately trained on the new scheme?
• What opportunity is there to optimise my team’s operational efficiency in managing and reporting shortages?

Contact Mary for a complimentary Optimising Team Effectiveness check.

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For my tips on preparing Regulatory Strategies, refer to my previous articles What I’ve learnt from preparing Regulatory Strategies… before you begin, and What I’ve learnt from preparing Regulatory Strategies… Now that you’ve started.

Ultimately, the success of your Regulatory strategy is determined not by you, and not even by your target Regulator(s), but by your organisation. So let’s take a look at a three typical reactions from your organisational audience, and how you might reflect on these to make your next strategy even better.

Scenario 1 – your proposed approach was met with an instantaneous and boisterous objection

Were there shortcomings in your Regulatory expertise? Whilst external support may plug such a gap, do check first for any untapped knowledge within your organisation or external network (this one with caution).

Ask yourself, were you blindsighted by the reaction your Regulatory Strategy received? If so, then it is likely your audience was blindsighted by your approach. Stakeholder engagement, particularly when presenting controversial advice, is invaluable. Next time pay closer consideration to who might have the biggest objection, and how you might engage with them prior to delivering your strategy. Often bold reactions are not to due Regulatory insufficiencies.

Scenario 2 – your documented Regulatory strategy was barely read, and instead you were asked to provide a verbal summary

Ask for feedback. Was it too long, too complex? Were key points lost in the technical blurr? Would a verbal summary or a three-slide Powerpoint have sufficed, at least initially?

Scenario 3 – the risks and challenges you raised were largely ignored

Did your strategy highlight these sufficiently? If not, then find another way to do so. If, however, risks and challenges did receive the right level of attention, then perhaps they weren’t ignored. Perhaps they were simply accepted as such by the those in your organisation with authority to do so, in which case, accept it and move on.

Five questions to consider as you reflect upon your Regulatory Strategy

• How was my Regulatory strategy received?
• What assumptions were missed or not challenged?
• Were risks and benefits quantified?
•  How could stakeholder engagement be improved?
• How could clarity of my Regulatory Strategy be improved?

Contact Mary for a complimentary Regulatory Strategy starter tip discussion or Regulatory Strategy assessment.

The post What I’ve learnt from preparing Regulatory Strategies – Making the next one even better… appeared first on Enimera RegsPlus.

So now you really are ready to write that Regulatory Strategy or to present a verbal overview at your next meeting. If you missed my previous tips to help you be ready, refer to my previous article What I’ve learnt from preparing Regulatory Strategies… before you begin.

If you are lucky, you’ll have a clear scope to workshop. Though often your ask will be something broader like identifying the most attractive markets for a new product pipeline. Either way, you are expected to champion the organisational objective and craft a competitive Regulatory Strategy.  Balancing the seemingly conflicting needs of your organization with those of the Regulator (or multiple Regulators, as is often the case) requires both Regulatory prowess and alignment to your organisational drivers.

But how can you do this when faced with an initiative that seems just plain crazy? Try playing in the space of possibilities – for example, a June submission date might be achievable if the Clinical Study Report were to be available earlier. Remember also to differentiate between laws and guidances, and watch out for the objective behind the objective – for example, sometimes Regulatory approval is a more pertinent milestone than the Regulatory filing date.

Buzz words like options, risks, costs, and time have important roles in good Regulatory Strategies – use them. Quantify risk and benefit (e.g. in terms of cost, time etc) and capture key non-direct costs such as resource impact.  Consult your network, both internal and external – of course, without disclosing sensitive information to external contacts –  you may be surprised at the intelligence you gain.

It may sound counterintuitive but knowing when to stop researching is absolutely fundamental, there is usually opportunity to further to dissect your strategy following initial discussion. Keep your Regulatory strategy succinct, and leave details for appendices or verbal discussion.

Finally, organisational drivers and Regulatory trends do evolve, so don’t be afraid to revise your strategy.

Here are a few more tips for you …

Five questions to consider whilst preparing a Regulatory Strategy

• What is in/out of scope?
• How might Regulatory or organisational assumptions be explored?
• What sources of Regulatory Intelligence might be helpful?
• Who are the key stakeholders?
• What Regulatory expertise might be helpful to engage?

The post What I’ve learnt from preparing Regulatory Strategies – Now that you’ve started…. appeared first on Enimera RegsPlus.

So you’ve been asked to prepare a Regulatory Strategy… good for you! You’ve been given an opportunity to contribute at a higher level and demonstrate how you bridge your technical expertise with your organisation’s drivers. Though consider yourself warned – even if you are up for challenges, preparing a Regulatory Strategy may both frustrate and excite you in equal measure.  And that’s not all – there’ll likely be an energetic exchange of views following close examination of your strategy.

Having prepared countless Regulatory Strategies, I’ve learned how important it is to consider a few things before putting finger to keypad. Whether your focus is a niche market or global saturation; a medicine, medical device, novel therapeutic or a line-extension… a few early considerations can be invaluable.

In my experience, overuse of technical jargon, misaligned assumptions and missed opportunities to challenge assumptions are all too-common findings in Regulatory Strategies. Embarking on a detailed investigation of Regulatory pathways when a short verbal overview at the next project meeting suffices, is another one. As is confusing strategy (the why and the how behind the proposed approach) with a plan (detailed milestones).

Your objective in preparing a Regulatory Strategy is to provide strategic advice to your organisation,  so remember to keep in check your personal views about the ask and to shift focus away from what you know to what your audience wants to know.

Here are a few more tips to get you going…

FIVE QUESTIONS TO CONSIDER PRIOR TO PREPARING A REGULATORY STRATEGY

• How does the particular initiative fulfil the organisational strategy?
• What deliverable is expected from you, and when is it due?
• Who is the audience?
• What assumptions or constraints are relevant, and which might be challenged?
• What is the risk appetite for this particular initiative?

The post What I’ve learnt from preparing Regulatory Strategies – before you begin… appeared first on Enimera RegsPlus.