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.

The post The Impact of the 2025 U.S Government Shutdown on FDA Activities: What Biotech and Pharma Need to Know appeared first on Enimera RegsPlus.

1.   Standard Pathway

Is the traditional route for registering prescription medicines in Australia, irrespective of whether your medicine is a new chemical or biological-derived medicine, a biosimilar medicine, or a generic medicine. While it might take longer than some of the expedited options, it remains a robust and thorough process, and at times, remains the only applicable pathway suitable for many prescription medicines.

Key features:

• Comprehensive TGA evaluation of quality, safety, and efficacy data
• Two-phased process: application screening followed by evaluation
• Legislated evaluation timeframe: 255 working days

This is the standard route for TGA prescription medicine approval, providing a structured evaluation to ensure safety and effectiveness in the Australian healthcare system.

2.   Provisional determination (fast track) pathway

Allows for early access to promising medicines based on preliminary evidence of efficacy, with further data required post-registration to convert the provisional registration to full registration. This TGA pathway is suitable for novel therapies showing early promise in treating serious conditions with limited treatment options.

Key features:

• Evaluation based on preliminary evidence of significant benefit for a major therapeutic advance
• Registration is conditional or “provisional”, with a second application required to convert to full registration
• Provisional registration is valid for two years with extensions up to six years
• Eligibility criteria apply, with confirmation through a “designation” application
• Target TGA evaluation timeline: 220 working days

This is one of the accelerated TGA pathways Australia offers to provide early access to qualifying  new medicines.

3.   Priority review (fast track) pathway

Accelerates the TGA evaluation process for medicines that address significant unmet medical needs

Key features:

• Faster evaluation time frame
• Requires evidence that the medicine provides a major therapeutic advance
• Eligibility criteria apply, with confirmation through a “designation” application prior to lodging the registration
• Target TGA evaluation time: 150 working days

This is the second accelerated TGA pathway for prescription medicine regulation in Australia.

4.   Comparable overseas regulators (COR)

Expedites TGA evaluation time frames by using completed assessment reports from recognised overseas regulatory agencies under relevant TGA pathways.

Key features:

• Work sharing and information exchange across regulatory agencies
• Potential for coordinated approvals in multiple markets
• Eligibility criteria apply and a checklist must be included with the application

This process helps streamline prescription medicine registration TGA, for medicines already approved by at least one recognised international authority.

5.   ACCESS pathway

Enables simultaneous evaluation across multiple countries, streamlining the approval pathway.

Key features:

• The Access consortium includes Australia, Canada, Singapore, Switzerland, and the United Kingdom, with work sharing and information exchange among these regulatory agencies

Potential for coordinated approvals in these regions

ACCESS supports faster and more efficient drug approvals and is becoming a key part of the TGA approval process in Australia, particularly for multinational sponsors entering several markets in parallel.

6.   Project Orbis

Specifically designed for innovative oncology medicines, this process is part of the TGA pathways and facilitates concurrent review and approval across participating regulatory authorities.

Key features:

• Expedited TGA review for cancer treatments, collaboration between TGA, USA FDA, Health Canada, and other regulators
• Potential for simultaneous multi-regional approvals

Project Orbis is a potential TGA pathway for organisations with an oncology product portfolio considering Australia as a potential market.

Complementary strategies to consider

In addition to selecting the most appropriate TGA pathway for your prescription medicine, other regulatory strategies are also worth assessing:

Orphan drug designation

• Offers fee waivers for treatments for rare diseases
• Eligibility criteria apply, with eligibility being confirmed through a “designation” application prior to lodging the registration application being lodged under the priority review pathway

Literature-based submissions

• worth considering for well established medicines with extensive published data
• reduces the need for sponsor conducted clinical or non clinical trials

Hybrid (mixed) applications

For applications where some but not all clinical or non clinical data is implemented with literature, making the right choice factors to consider

Making the Right Choice: Factors to Consider

When selecting a TGA pathway, consider the following:

1. Your product’s stage of development
2. The strength and completeness of your clinical data
3. The urgency of patient need for your medicine
4. Your global regulatory strategy
5. Available resources and timelines
6. The competitive landscape in your therapeutic area

Expert guidance for navigating TGA pathways

At Enimera RegsPlus, we understand that choosing the right TGA pathway is a critical decision which can impact patient access to your medicine, and also your medicine’s success in the Australian market. Our team possesses extensive experience across TGA pathways to guide you through the key considerations in developing your TGA regulatory strategy.

Get in touch with today to schedule a strategy call and take the first step towards successful TGA registration of your prescription medicine.

The post Navigating TGA Pathways for Prescription Medicines in Australia: A Brief Overview appeared first on Enimera RegsPlus.

WHAT I’VE LEARNT FROM PREPARING REGULATORY STRATEGIES – BEFORE YOU BEGIN….

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 regulatory strategies 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 fingers 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 organization, 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 – this is the essence of strategic regulatory planning.

“…there’ll likely be an energetic exchange of views following close examination of your strategy”

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?

When done right, regulatory strategy development offers a unique opportunity to align scientific, business, and compliance goals from the outset.

Part 2

What I’ve learnt from preparing Regulatory Strategies – Now that you’ve started….

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 guidance and watch out for the objective behind the objective – for example, sometimes Regulatory approval is a more pertinent milestone than the Regulatory filing date.

Buzzwords 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 fundamental, there is usually an opportunity to further 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.

 “Quantify risk and benefit”

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?

In some cases, bringing in regulatory affairs consulting expertise can help you validate your assumptions and refine your recommendations with deeper market insight.

Part 3

What I’ve learnt from preparing Regulatory Strategies – Making the next one even better…

Relief! Your regulatory strategy is complete.  Now for the feedback, are you ready for it?

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 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 blindsided by the reaction your regulatory strategy received? If so, then it is likely your audience was blindsided 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 due to 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 blur?  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 those in your organisation with authority to do so, in which case, accept it and move on.

“Ultimately, the success of your regulatory strategy is determined … by your organisational audience”

Expect that an important organisational objective will elicit passionate and lively discussion – that’s why you’ve been tasked with developing a regulatory strategy

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 the clarity of my regulatory strategy be improved?

Robust regulatory planning should be iterative. Every strategy is an opportunity to improve alignment, engagement, and value delivery.

For a complimentary regulatory strategy starter tip discussion or regulatory strategy assessment, email me on mnteris@enimeraregsplus.com.au

The post What I’ve learnt from preparing Regulatory Strategies Part 1 – 3 appeared first on Enimera RegsPlus.

How many of these key messages resonate with you?

1. The U in VUCA– be comfortable with a level of Uncertainty as Uncertainty is unavoidable – in fact, one can even say it is . . .  certain.
2. The importance of self-awareness as leaders – knowing your go-to habits or behaviours and also knowing how to adapt to lead effectively at this time.
3. It IS possible to connect well with team members and colleagues who are now working remotely  – it may mean you need to encourage conversations which go beyond the simple task-based check-in.
4. Focus on what is within your control, and keep doing it well – being agile and collaborative, for example, is an attitude we all can choose to hold.
5. Professional development – may be propelled for some, for others it may have stagnated . . . for now.
6. Well-being – create an environment which encourages individuals to speak up when they need help.
7. Be-ing well – these days, separation of work from non-work is more of a challenge for many.
8. Video conferencing comedies – pets, children, neighbouring construction work… can be both fun and funny.
9. Camera conundrums – camera on? camera off? Be flexible.
10. Practicalities– embrace enabling technology and ensure you have an office-from-home set-up which facilitates working at your best.

A special thanks to panellists Helen Critchley, Liz Joshi, Geraldine Storton and Jo Turner for sharing their insights and tips with the conference attendees.

And congratulations to ARCS for bringing together a great virtual conference.

………

Interested in on-line Regulatory training or mentoring from an experienced leader?  Check out the Enimera RegsPlus Learner Leader Modules in Regulatory Affairs

The post How has the COVID-19 pandemic impacted Regulatory professionals? appeared first on Enimera RegsPlus.

So how do two letters distinguish between two regulatory pathways, and how to remember the difference?

BiologicALs vs Biologics – two letters to FMT

The post BiologicALs vs Biologics – two letters to FMT appeared first on Enimera RegsPlus.

Flexible and engaging, tutorial access over six or nine months, and with the option to complement the learning with mentoring and a Certificate of Completion.

Enimera RegsPlus Learner Leader Modules in Regulatory Affairs

The post Introducing new online learning in Regulatory Affairs appeared first on Enimera RegsPlus.

The post Regulator Interactions During COVID-19 appeared first on Enimera RegsPlus.

The post Global Regulatory Projects: Best Practices appeared first on Enimera RegsPlus.

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.

“… It took:

a.    40 years to get 50 million radios on earth.

b.    14 years to get 50 million TVs.

c.    1 year to get 50 million Facebook accounts.

d.    4 months for 50 million WeChat accounts.”

Fascinating.

Relevant to organisational vision and strategy, yes.

Relevant to commercially-oriented functions, yes.

Relevant to scientifically-oriented functions within the therapeutics and wellness sectors?  Absolutely.

Functions like Regulatory Affairs, Medical Affairs, Clinical Research and others are often described by their organisational counterparts as being slow, overly conservative and resistant to changing organisational priorities.

So let’s get a little scientific (or somewhat mathematical) about agility…

• Agility ⇒ being quick and nimble, adjusting to changing priorities without ‘drag’
• Agility ⇏ disregard for compliance
• Agility + other team attributes = effective business partnering.

So I challenge you to hold up your agility mirror in the context of your team’s performance.

THREE QUESTIONS TO ASK YOURSELF WHEN HOLDING UP THE AGILITY MIRROR

• How is your function often described by others?
• What are your top three operational bottleneck or ‘drag’ areas?
• What is your team’s collective agility profile?

[1] May 2019, The Digital Director – Are you ready? Nicole Donegan, COO, Women on Boards

Could your team benefit from productivity lift? In addition to traditional Regulatory consulting services, Mary offers team operational effectiveness checks and support.

Contact Mary for a complimentary Team Effectiveness Check.

The post The agility mirror for scientifically-oriented teams appeared first on Enimera RegsPlus.