Pharma/Biotech – USA, Europe Regulatory News, Sept 2023 Vol. 1
USA
FDA Releases Guidance on EPCIS Standard for DSCSA and Pulmonary Disease Drug Development
The FDA has advised that trading partners use the GS1-developed Electronic Product Code Information Services (EPCIS) standard to comply with the Drug Supply Chain Security Act (DSCSA), as noted in its latest guidance.
FDA Publishes Three Final Guidances on Real-World Data and DSCSA
Three final guidance documents were issued—one addressing the use of real-world data (RWD) in non-interventional studies, and two focusing on compliance under the DSCSA framework.
FDA Extends DSCSA Enforcement Deadline to November 2024
The FDA announced that it will delay enforcement of DSCSA requirements for electronic drug tracking at the package level until November 27, 2024, to allow additional time for industry readiness.
FDA Releases Product-Specific Guidance for Generic Drug Development
New draft and revised product-specific guidances have been issued to support bioequivalence study design for ANDA submissions, facilitating generic drug availability.
FDA Finalizes Informed Consent Guidance
Following nine years in draft status and stakeholder input, the FDA finalized its guidance on the informed consent process, adding a Q&A section to address key industry concerns.
Combination Product Regulations Need Further FDA Clarification
Industry experts continue to call for more FDA guidance on combination product regulation. Determining lead responsibility between CDRH, CBER, or CDER remains complex and insufficiently explained through current documentation.
FDA Draft Guidance on BsUFA III: Classification and Meetings
Two new draft guidances outline FDA’s recommendations on biosimilar classification categories and formal meeting procedures under BsUFA III.
Post-Approval Diverse Patient Data Collection Guidance
The FDA issued draft guidance emphasizing the importance of collecting data on underrepresented patient populations after drug approval when pre-approval diversity is limited.
Industry Pushback on Medicaid Drug Rebate “Stacking” Rule
Major pharmaceutical associations have objected to the CMS-proposed rule revising the “best price” definition under the Medicaid Drug Rebate Program, citing concerns about its “stacking” requirement.
FDA Draft Guidance on Post-Warning Letter Meetings
The FDA issued a draft guidance explaining how facilities can request post-warning letter meetings under GDUFA III to discuss corrective actions for GMP deficiencies.
FDA and EMA Publish Nitrosamine Guidance
Both agencies released guidance documents addressing detection, measurement, and risk-based control of nitrosamine impurities in pharmaceuticals, outlining acceptable intake limits and quality expectations.
FDA Guidance and Congressional Oversight on DSCSA Implementation
FDA’s final guidance details how manufacturers can seek waivers, exemptions, or exceptions under DSCSA, while lawmakers inquire about industry preparedness for its final phase.
FDA and DEA Urge Increased ADHD Drug Production
In a joint letter, the FDA and DEA urged manufacturers to maximize production within quota limits to mitigate ADHD medication shortages, encouraging coordinated action among supply chain stakeholders.
ICH E6(R3) Draft Proposes Major Overhaul of GCP Standards
The third revision of ICH E6 introduces a full restructuring of global good clinical practice standards, focusing on modernized oversight for sponsors and investigators.
FDA Publishes Additional DSCSA Enforcement Delay Guidance
The FDA issued two more guidance documents clarifying policies on the one-year delay of DSCSA electronic tracking enforcement, offering further direction for manufacturers and distributors.
EUROPE
EMA Updates on Parallel Distribution FAQs
The EMA has revised its FAQs on parallel distribution, covering procedures for organizational detail changes, validity and revocation of distribution notices, and submission of bulk changes.
Coordinating Clinical Trials in EU Public Health Emergencies
A recent EMA report outlines proposed EU-level measures to improve clinical trial coordination during public health crises, incorporating lessons from COVID-19 and Mpox outbreaks to streamline evidence generation.
Guidance Update on Preparing and Reviewing Product Characteristics Summaries
The EMA updated its guidance on preparing and reviewing summaries of product characteristics, refining instructions for defining therapeutic indications and pediatric bodyweight criteria during new drug assessments.
Enhanced Transparency Through Updated Risk Management Plan Publications
From October 20, 2023, EMA will publish full RMPs, replacing previous summary formats, to enhance transparency around safety evaluations for centrally authorized medicines.
Good Clinical Practice (GCP) Q&A Update
EMA’s updated Q&A clarifies expectations for distributing revised Investigator’s Brochures (IBs) and Informed Consent Forms (ICFs) to investigators and trial sites.
Updated Guidance for MAHs on Oral Explanations at EMA
The EMA revised its guidance for Marketing Authorization Holders (MAHs) on conducting oral explanations before committees and advisory groups, providing clearer procedures for effective communication during review processes.
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