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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.

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.

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Draft guidance on redundancy risk management plans layers risk-based expectations over new statutory requirements to plan more resilient supply chains for critical drugs.
Spotlight On Coronavirus
EMA: First Adapted COVID-19 Vaccines Expected In September
As work continues on vaccines adapted to tackle variants of SARS-CoV-2, the EU regulator says the decision-making on such products should take place at a global level.
COVID-19 Vaccines: Spikevax Review Reflected Changing Realities Of Omicron In US
COVID-19 Vaccines In Five And Younger Could Get Earlier FDA Advisory Committee Review
Coronavirus Notebook: WHO Says Extra Vaccine Boosters Confer Some Limited Benefits, Emergex & Zosano Link Up On T Cell Vaccine Patch
US FDA To Train Investigators On mRNA Vaccine Manufacturing
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Pink Sheet Podcast
Keep up with latest biopharma regulatory and policy developments with Pink Sheet podcasts.
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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

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.
European Performance Tracker
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.
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.
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.
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.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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.
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.
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.”
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.
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.
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.
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.
Commercial Explore this Topic
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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.
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.
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.
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.
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.
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.
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