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Selvita Completes Acquisition of PozLab
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Selvita Completes Acquisition of PozLab
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FDA Watch
All
Drug Discovery and Development
Contract Manufacturing
Packaging
Compliance
Regulatory Affairs
FDA and Field Alert Reports
Analysis of “Field Alert Report Submission Questions and Answers Guidance for Industry”
Constance Richard-Math, Lachman Consultants
09.11.18
Regulatory Affairs
Elemental Impurity & Risk Assessment
An update on the retirement of USP General Chapter <231>.
Paul Mason, Lachman Consultants
07.20.18
Regulatory Affairs
|
Solid Dosage/Creams/Ointments
Semi-Solids: A Regulatory Perspective
Compliance of semi-solid dosages to FDA Stage III Continuous Process Verification.
José L. Toro, Ph.D., Lachman Consultants
06.12.18
Regulatory Affairs
GDUFA II: Do You Have a Strategy?
Generic companies continue to face multiple challenges in an ever-increasing competitive market place
Janis A. Picurro, Lachman Consultants
05.08.18
Regulatory Affairs
Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle: ICH Q12
...
Sharif Ahmed, Lachman Consultants
04.10.18
Information Technology
|
Regulatory Affairs
FDA’s Increased Information Transparency
...
Ricki A. Chase, Lachman Consultants
03.09.18
Regulatory Affairs
Avoiding Sponsor-Supplier Relationship Pitfalls
The right CMO-sponsor relationship can result in mutually beneficial outcomes
11.07.17
Regulatory Affairs
ANDA Refuse-to-Receive Pitfalls and How to Avoid Them
A review of FDA expectations
Jean Poulos, Lachman Consultants
10.11.17
Regulatory Affairs
|
Supply Chain
Supply Chain Risk Mitigation
Addressing the inherent risks in an increasingly fragmented supply chain
Nuala Calnan, Lachman Consultant Services
09.06.17
Regulatory Affairs
Data Integrity Guidance Around the World
A look at data integrity controls and the overall framework for a data governance system.
James Davidson, Ph.D, Lachman Consultants
07.18.17
Inspections
|
Regulatory Affairs
Warning Letters & Close-out Letters
Why does it take so long to get a close-out letter?
06.06.17
Regulatory Affairs
The FDA and Metrics
The Agency and industry continue to work together to achieve FDA’s objectives
David Lonza, Lachman Consultant Services, Inc.
05.09.17
Regulatory Affairs
Establishments, Identifications, Submissions and Beyond
A closer look at electronic submissions of manufacturing establishment information (MEI).
Sharif Ahmed, Lachman Consultants
04.03.17
Regulatory Affairs
Challenges and Advantages of International Regulatory Inspections
A look at the processes and approaches followed by FDA
Daniel Barreto, Lachman Consultants
03.07.17
Inspections
cGMP Enforcement, the False Claims Act and Lessons From Omnicare
Mere evidence of noncompliance may not be enough, when attempting to enforce cGMPs via the False Claims Act
04.03.14
Clinical Trials
|
Validation
New Rules on Medicinal Product Clinical Trials in Europe
...
Genevieve Michaux, Hunton & Williams LLP
03.07.14
Inspections
New Compounding Legislation
...
Sheldon Bradshaw & Sharon Bradley, Hunton & Williams LLP
01.24.14
GMPs/GCPs
|
Information Technology
|
Inspections
|
Regulatory Affairs
Mobile Medical Apps
There's an FDA guidance for that
Kyle Sampson and Allison L. Reschovsky, Hunton & Williams LLP
11.13.13
Clinical Trials
|
Extractables and Leachables
|
Facilities
|
GMPs/GCPs
|
Inspections
|
Methods Development
|
Process Development
|
QA/QC
|
Regulatory Affairs
|
Validation
IRBs and INDs
Evaluating IRB responsibilities and determining IND exemptions
Heather D. Banuelos, Hunton & Williams LLP
10.09.13
Regulatory Affairs
Withdrawing for Safety
FDA adopts case-by-case approach for opioid analgesics
Kyle Sampson, Hunton & Williams LLP
09.05.13
Breaking News
Selvita Completes Acquisition of PozLab
BioVersys, GSK Expand Strategic TB Collaboration
Cellipont Bioservices, Adva Biotechnology Partner to Optimize Cell Therapy Mfg.
ARTBIO, Nucleus RadioPharma Enter Manufacturing & Supply Pact
GRAM Expands Syringe and Cartridge Capacity
View Breaking News >
CURRENT ISSUE
April 2024
Anti-Counterfeiting Technology
Navigating Global CDMO Trends
Weight-loss Drug Packaging
Clinical Supply CDMOs
Industry Experts Weigh in on Oral Solid Dosage
Newsmakers Q&A: Almac Group
Economical Mobile Workstations for Lower-Grade Cleanrooms
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