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US FDA To Explore New Regulatory Pathways For Some Cellular Products

Agency re-evaluating criteria for certain human cells, tissues and cellular and tissue-based products (HCT/Ps) that are not ideally regulated as BLAs; industry suggests a 2014 guidance which created an alternative pathway for cord blood products could serve as potential template.

Regenerative Medicine Biologics Review Pathway

House GOP Targets US FDA Applications With China-Only Data, Raise General Oversight Concerns

While industry concern with FDA’s policy shift on clinical data from China has focused on the disruption in business plans, Republican lawmakers appear to feel that the agency has not gone far enough and are seeking a GAO review of FDA’s entire bioresearch monitoring program.

Clinical Trials China Regulation

US FDA Supply Chain Guidance Includes More Stakeholders, More Risks Than CARES Act

Draft guidance on redundancy risk management plans layers risk-based expectations over new statutory requirements to plan more resilient supply chains for critical drugs.

Supply Chain Quality Risk Management

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Pink Sheet Podcast

Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.

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Performance Trackers

Keeping Track: Lilly’s Mounjaro Enters Diabetes Market; Biogen/Eisai Lecanemab Leads Neuroscience News

CDER turned in its 13th novel approval of 2022 on Friday the 13th, and other drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals Drug Review


Global Pharma Guidance Tracker – April 2022

Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

Guidance Documents Regulation International

Policy & Regulation Explore this Topic

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Latest From Regulation

ERC Not Giving Up On Glioma Immunotherapy In EU

ERC Belgium has pledged to collect more data to convince the European Medicines Agency that Sitoiganap merits approval. Meanwhile, UGA Biopharma said it would address the agency’s objections over its biosimilar version of eptacog alfa.

Drug Review Regulation

Philippines Considers Regulatory Reliance To Speed Up Evaluating Trial Applications

The Philippines FDA is looking to leverage the work conducted by “stringent” regulators when it comes to reviewing certain clinical trial applications.

Philippines Clinical Trials

Inhaler Changes For Environmental Reasons Worry Generic Sponsors, Prompt Call For FDA Research

ANDA sponsors say eliminating the HFC propellant, while important to help address climate change, could upend the generic market without guidance from the US FDA.

Generic Drugs Combination Products

US FDA and ARPA-H: Woodcock Has Questions

The FDA’s principal deputy commissioner wonders how the agency will work with ARPA-H to help get its projects to patients and the health care system given its other responsibilities.

Research & Development Legislation

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered. 

Advisory Committees Drug Review

PTC’s ‘Life-Changing’ Gene Therapy Among Nine Drugs To Win EU Thumbs Up

The European Medicines Agency has delivered its verdict on the latest medicines it believes should be approved for marketing in the EU. By contrast, it has given the thumbs down to one biosimilar anticancer drug and its duplicate.

Europe Approvals

Latest From Policy

Senate Commerce Leaders Want An FTC Study Into PBM Business Practices – And More

Committee Chair Maria Cantwell (D-Wash.) solicits advice from witnesses for additional authorities to conduct oversight of PBMs and pushes for a GAO study.

Pricing Debate Policy

Fear of Unpredictability: Industry Criticises Japan’s Frequent Pricing Rule Changes

While Japan enters annual drug price revisions with frequent regulation changes, several major corporate players in the country warn again that government policies mean that the country is at risk of “losing attractiveness.”

Japan Policy

England’s Innovative Medicines Fund To Put Spotlight On Rare Disease Treatments

While the much-anticipated Innovative Medicines Fund is likely to benefit rare diseases in particular, other products must gain too.

Cost Effectiveness United Kingdom

Clinical / R&D Explore this Topic

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Latest From Research & Development

US FDA and ARPA-H: Woodcock Has Questions

The FDA’s principal deputy commissioner wonders how the agency will work with ARPA-H to help get its projects to patients and the health care system given its other responsibilities.

Research & Development Legislation

Gene Therapy Development Should Involve Fewer Surprises, Says US FDA’s Marks

Regulators want to help smooth the process of bringing a gene therapy to market, hoping to iron out ‘surprises’ and even address reimbursement issues for the sake of patients.

Commercial Clinical Trials

Coronavirus Notebook: WHO Says Extra Vaccine Boosters Confer Some Limited Benefits, Emergex & Zosano Link Up On T Cell Vaccine Patch

International regulators have issued an updated statement on the benefits and safety of COVID-19 vaccines for use by health professionals, while the UK BioIndustry Association has welcomed a MAb licensing deal between AstraZeneca and UK-based biotech firm RQ Bio.

International Coronavirus COVID-19

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Latest From Commercial

Gene Therapy Development Should Involve Fewer Surprises, Says US FDA’s Marks

Regulators want to help smooth the process of bringing a gene therapy to market, hoping to iron out ‘surprises’ and even address reimbursement issues for the sake of patients.

Commercial Clinical Trials

Aduhelm Label Update Includes Seizure Risk And Recommends More MRIs

New safety information may help defense of CMS's coverage restrictions. FDA updated the prescribing information for Biogen’s Alzheimer's therapy after four cases of seizures were reported in a trial.

Neurology Drug Safety

FTC’s Take On Two Pharma Mergers Shows Deals Can Clear Higher Hurdle

Pfizer’s acquisition of Arena without FTC intervention and Hikma’s acquisition of Custopharm with one product divestiture shows the commission is bound by anticompetitive facts of a deal. A more controversial merger may not get through, former FTC attorney says.

M & A Commercial

Manufacturing Explore this Topic

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Latest From Manufacturing

More Change With Less Hoopla To FDA Out-Of-Specification Investigations Policy

Agency’s revised OOS guidance clarifies positions on outlier test results, averaging of HPLC results and some finer points around OOS questions. These could marginally improve compliance but won’t impact industry with nearly the force of the original 2006 guidance or the 1993 court ruling that preceded it.

Manufacturing Quality

UK MHRA Specifies Eligibility For Consultancy Firms To Monitor GMP, GDP Compliance

Consultancy firms must have at least five years of experience in carrying out independent GMP or GDP audits if they want to apply to become a “compliance monitor” under a new MHRA scheme to keep track of drug companies that fail to comply with GMP/GDP requirements. 

Compliance Manufacturing

Japan Passes New Economic Security Bill – What's The Pharma Impact?

Japan has passed a new law which will require the providers of certain products to cooperate in securing supplies to the country. For the pharma industry, there are a couple of signs which specific drugs will be within the scope of the legislation and how this will impact the sector.

Japan Policy
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