Agencyiq company information, Employees & Contact Information

Following layoffs, the future of FDA’s user fee programs is in extreme jeopardy AgencyIQ by POLITICO

Analysis: The scope and contents of CDER’s draft guidance portfolio AgencyIQ by POLITICO

Analysis: The majority of novel drugs approved by FDA rely on evidence from a single pivotal trial AgencyIQ by POLITICO

A guide to staff reductions FDA has already experienced – and those coming soon AgencyIQ by POLITICO

As government reform efforts converge, significant FDA staff cuts are likely AgencyIQ by POLITICO

What Trump’s executive orders would mean for the FDA and life sciences industry AgencyIQ by POLITICO

FDA begins restoring some documents following court order AgencyIQ by POLITICO

RFK Jr. is confirmed as HHS secretary. What now? AgencyIQ by POLITICO

Trump reintroduces revamped deregulatory executive order: One in, 10 out, and a bigger role for the Unified Agenda AgencyIQ by POLITICO

Under new executive order, FDA to prep for DOGE-directed reductions in force AgencyIQ by POLITICO

What CDER Director Patrizia Cavazzoni’s retirement means for FDA AgencyIQ by POLITICO

Legislators tee up renewed effort to pass rare pediatric drug bills AgencyIQ by POLITICO

What does Trump’s order on deregulation mean for the chemicals industry? AgencyIQ by POLITICO

Trump establishes MAHA Commission, with medicines – and maybe user fees – in its crosshairs AgencyIQ by POLITICO

The Trump Transition: The future regulatory philosophy of the FDA is still a mystery AgencyIQ by POLITICO

FDA’s new accelerated approval guidance offers detail on withdrawals process, but punts on confirmatory studies AgencyIQ by POLITICO

The Trump Transition: RFK has been nominated to lead HHS. What now? AgencyIQ by POLITICO

The Trump Transition: How could Trump’s DOGE affect the FDA? AgencyIQ by POLITICO

The Trump Transition: What Marty Makary could mean for FDA if he’s confirmed as the next commissioner AgencyIQ by POLITICO

FDA buries the lede on a key benefit of multiregional clinical trials: More trustworthy data AgencyIQ by POLITICO

Digital Health Update: HHS’ new AI Office, FDA’s report on AI in surveillance – and coming policy AgencyIQ by POLITICO

Your essential guide to the FDA regulatory policy landscape through the end of 2024 AgencyIQ by POLITICO

Understanding the nuts and bolts of the reauthorization process for PDUFA VIII AgencyIQ by POLITICO

The FDA is in dire need of some regulatory design thinking AgencyIQ by POLITICO

FDA and EMA re-launch parallel advice pilot for complex generics AgencyIQ by POLITICO

EPA’s toxicological review of PFNA gets mixed reviews from government, industry AgencyIQ by POLITICO

Trump may hand control of FDA over to RFK Jr. Here’s what that could mean for FDA and industry AgencyIQ by POLITICO

New FDA guidance on addressing misinformation under White House review AgencyIQ by POLITICO

How FDA is already requiring companies to study the safety and effectiveness of their approved drugs in diverse populations AgencyIQ by POLITICO

To combat antimicrobial resistance, the FDA needs a reset AgencyIQ by POLITICO

Accelerated Removal: FDA making use of new authority to withdraw ineffective drugs more quickly AgencyIQ by POLITICO

FDA further blurs the line between biosimilars and interchangeables AgencyIQ by POLITICO

New regulatory ‘playbook’ from FDA-supported Bespoke Gene Therapy Consortium aims to accelerate development AgencyIQ by POLITICO

The Artificial Intelligence Executive Order: What does it mean for FDA and its regulated industries? AgencyIQ by POLITICO

FDA quietly kicks off process that could inform future rare disease regulatory reforms AgencyIQ by POLITICO

Following a 2018 draft framework, FDA unveils long-awaited PDURS draft guidance AgencyIQ by POLITICO

European Commission issues EU-wide rules on pesticide ingredients AgencyIQ by POLITICO

Everything the FDA does is a violation of the Administrative Procedure Act AgencyIQ by POLITICO

EU Commission to add dozens of chemicals to PIC Regulation AgencyIQ by POLITICO

How the FDA’s new LDT regulation could affect drug development AgencyIQ by POLITICO

What we’ve heard at CDRH’s recent medical device sterilization town halls AgencyIQ by POLITICO

Revised guidance on Covid-19 symptom assessment incorporates new knowledge, adds flexibility AgencyIQ by POLITICO

How FDA’s Laboratory Developed Test rule could delay some drug approvals AgencyIQ by POLITICO

How a failed ALS drug provides a blueprint for the FDA to create a ‘Conditional Withdrawal’ pathway AgencyIQ by POLITICO

CDER’s latest novel drug approvals report shows how the pandemic is still affecting some drug approvals AgencyIQ by POLITICO

What we expect European regulators to do in December 2023 AgencyIQ by POLITICO

Has the FDA lost the plot on surrogate endpoints? AgencyIQ by POLITICO

EMA’s 2023 new medicines report suggests return to pre-pandemic volume AgencyIQ by POLITICO

New FDA guidance on interchangeable biosimilar labeling heads to White House for review AgencyIQ by POLITICO

FDA gives companies leeway to go after misinformation, but not free reign AgencyIQ by POLITICO

FDA holds the line on remanufacturing definitions in newly finalized guidance AgencyIQ by POLITICO

FDA looking to beef up its remote assessments with artificial intelligence AgencyIQ by POLITICO

New MDR/IVDR standardization request adds standards, moves deadlines AgencyIQ by POLITICO

EMA publishes Union list of critical medicines AgencyIQ by POLITICO

Diagnostics landscape analysis: Key issues and a look ahead at 2024 AgencyIQ by POLITICO

FDA flexes its new accelerated approval authorities, hoping to accelerate access to confirmatory data AgencyIQ by POLITICO

Explainer: What a government shutdown would mean for the FDA (Updated) AgencyIQ by POLITICO

FDA outlines its approach to new meeting types focused on generic drugs AgencyIQ by POLITICO

The new drug pricing legislation: What regulatory professionals need to know AgencyIQ by POLITICO

As we wait for FDA’s Fall 2022 Unified Agenda, a look at what regulations are likely ahead for next year AgencyIQ by POLITICO

FDA updates set the stage for broader use of harmonized standards for safety reporting AgencyIQ by POLITICO

FDA comes full circle with new guidance on testing products for toxic ingredients DEG and EG AgencyIQ by POLITICO

Congress pushes for new FDA authorities to identify and address drug shortages AgencyIQ by POLITICO

The FDA rejected a psychedelic sponsor’s bid for approval. Here are six industry takeaways AgencyIQ by POLITICO

EPA publishes interagency framework on antifungal and antibiotic resistance from pesticides AgencyIQ by POLITICO

FDA unveils details about major proposed changes to organization, including ORA and Office of the Commissioner AgencyIQ by POLITICO

New guidance provides definition for orphan device, offers alternative trial designs AgencyIQ by POLITICO

Five key takeaways from FDA’s 2022 advisory committee meetings AgencyIQ by POLITICO

FDA releases long-overdue guidance on content and format of OTC drug submissions AgencyIQ by POLITICO

ECHA unveils 6-month plan to evaluate universal PFAS restriction proposal AgencyIQ by POLITICO

MHRA, FDA and Health Canada offer “guiding principles” for predetermined change control plans AgencyIQ by POLITICO

EPA Withdraws Glyphosate Interim Registration Review Decision AgencyIQ by POLITICO

EFSA’s novel BPA assessment approach defended amid national regulatory dissent AgencyIQ by POLITICO

Swissmedic reorg adds new focus on medical device market surveillance AgencyIQ by POLITICO

The FDA wants to kill the interchangeable biosimilar. It’s not waiting on Congress to start the burial preparations AgencyIQ by POLITICO

FDA’s Plan to Study Accelerated Approval AgencyIQ by POLITICO

3M PFAS settlement gains final court approval AgencyIQ by POLITICO

FDA unveils long-awaited Patient Medication Information proposed rule AgencyIQ by POLITICO

EMA issues more updates to prepare for clinical trials transition AgencyIQ by POLITICO

FDA’s new guidance explains what to do during a BIMO inspection AgencyIQ by POLITICO

The European Commission launches a new Critical Medicines Alliance AgencyIQ by POLITICO

British regulators tease new device regulations in informative live session AgencyIQ by POLITICO

FDA finalizes guidance on electronic submissions for OTC products AgencyIQ by POLITICO

CDER unveils new guidance agenda for 2023, with 42 new policies planned AgencyIQ by POLITICO

What you need to know about the status of the proposed EMA fees regulation AgencyIQ by POLITICO

AgencyIQ Guidance Tracker: European medical device and diagnostics guidance documents AgencyIQ by POLITICO

Center for Food Safety sues EPA over unanswered petition on inert ingredients in pesticides AgencyIQ by POLITICO

Key takeaways from FDA’s contracted report on legacy medical device cybersecurity AgencyIQ by POLITICO

Why comprehensive state-level bans on PFAS in products are faltering AgencyIQ by POLITICO

EPA finalizes Contaminant Candidate List 5, includes multiple PFAS structures AgencyIQ by POLITICO

FDA proposes first update to orthopedic device coating guidance since 1990s AgencyIQ by POLITICO

EPA orders manufacturer to stop producing PFAS and manufacturer petitions court AgencyIQ by POLITICO

Commission proposes exemptions to UV-328 ban under POPs Regulation AgencyIQ by POLITICO

With all nitrosamines deadlines passed, EMA updates its guidelines AgencyIQ by POLITICO

Commission designates first E.U. Reference Laboratories for class D IVDs AgencyIQ by POLITICO

Addressing benzene contamination, FDA issues guidance for reformulating products containing certain carbomers AgencyIQ by POLITICO

FDA releases BsUFA III Commitment Letter outlining proposed changes to biosimilar development pathway AgencyIQ by POLITICO

For first time, FDA releases OTC drug user fees prior to start of government fiscal year AgencyIQ by POLITICO

French PFAS ban exempts cookware, clears National Assembly AgencyIQ by POLITICO

EPA and GE Agree on PCB Research Plan for Hudson Valley AgencyIQ by POLITICO