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FDA sends warning to companies selling unapproved CBD products
The warning letters were issued to two companies illegally selling over-the-counter cannabidiol (CBD) products for pain relief.
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Fresenius Kabi Oncology Ltd to pay $50mn for destroying records ahead of an FDA Inspection
The Indian drug company pleaded guilty to concealing and destroying records containing evidence of its Kalyani plant manufacturing drugs in contravention to FDA requirements prior to a 2013 inspection.
news
Pfizer’s COVID-19 vaccine data accessed in EMA cyber-attack
Pfizer and BioNTech told that documents relating to their COVID-19 vaccine approval were accessed during a cyber-attack on the European Medicines Agency (EMA).
article
The future of label management is with intelligent automation
Kiran Chinnalla and Julian Backhouse explain why automation for labelling in pharma can help the industry to remain compliant in the face of regulatory changes.
news
Certificates of Compliance or Attestation of Conformity have no legal standing under UK Medical Device Regulations 2002
The UK’s MHRA has stated that manufacturers must instead issue a Declaration of Conformity to Directive 93/42/EEC and register their Class I medical device with an EU Competent Authority.
article
Trademarks in the medical sphere: practice, examination and obstacles for registration in Russia, Ukraine and the CIS
Dr Tatiana Lipovaya and Alyona Chernoknyzhnaya discuss some of the main considerations when applying for trademarks in the pharmaceutical industry in Russia, Ukraine and the CIS.
news
Kymab wins UK court case against Regeneron’s patent claims
The UK Supreme Court has ruled that Regeneron's patent claim regarding genetically modified mice against Kymab are invalid.
article
Patents and approvals – medicines, vaccines and diagnostics for COVID-19
As companies race to develop a COVID-19 vaccine, various discussions about patents and ownerships of the vaccine have occurred, especially in light of funding from various governments. This article explores the patent and regulation issues, with a focus on patent extensions and suspensions for global good.
news
Epidyolex (cannabidiol) reclassified as Schedule 5 in UK, relaxing control over drug
GW Pharmaceuticals's Epidyolex (cannabidiol) has been changed from a Schedule 2 drug to a Schedule 5 drug, making it exempt from virtually all controlled drug requirements.
news
UK CMA disqualifies pharma company director after breaking competition law
A pharmaceutical company director is now banned from holding a director role at any UK company for the next five years after making illegal arrangements.
news
FTC accepts proposal for AbbVie to acquire Allergan for $63 billion
AbbVie and Allergan have announced the Federal Trade Commission has accepted AbbVie's pending acquisition of Allergan for $63 billion.
news
EMA to fast-track development of COVID-19 vaccines and therapeutics
The EMA has announced new regulatory changes that will help potential COVID-19 vaccines and therapeutics accelerate through development.
news
Gilead files lawsuit against US federal government over alleged contract breaches
Gilead's complaint alleges five contract breaches by the US Centers for Disease Control and Prevention (CDC) and seeks a declaration of contract breach and damages.
article
Four MHRA ‘inspections and good practice’ guidances for the COVID-19 outbreak
Md Saddam Nawaz discusses four guidances released by the MHRA to help firms navigate the regulatory waters during the COVID-19 pandemic.
news
FDA sends two warnings to companies selling unapproved CBD products
Two companies selling unapproved cannabidiol (CBD) products including for the treatment of opioid addiction, have been handed warning letters from the FDA.
