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.

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.