Regulatory and Legal
Search Results 1 - 10 of 157 recordsBiologics Price Competition and Innovation Act
(Technical Article, 28 Jun 2010 )The Patient Protection and Affordable Care Act (PPAC Act), signed into law by US President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated approval pathway ....
US FDA and NIH Launch Web-based Safety Reporting Portal
(Business News, 09 Jun 2010 )US FDA and the National Institutes of Health (NIH) launch the Safety Reporting Portal (SRP) web site allowing increased accessibility to submit reports concerning FDA regulated products. Product Manufacturers, ....
Regulatory Compliance of Equipment Qualification
(Regulatory, Jun 2010 )The requirement of European and US companies for on-site auditing of active pharmaceutical ingredients (API) manufacturers has added pressure to countries like India and China to conform. Yet compliance ....
Actavis Opens Beijing Office
(Business News, 20 May 2010 )Actavis has established a regional office for China at Beijing's Youth Plaza Office Building. The office will primarily handle registrations for imported products and related regulatory issues, as well ....
DHL Prepares Pharmaceutical Shippers for Cargo Screening
(Business News, 01 Apr 2010 )DHL in partnership with American Airlines Cargo, is supporting pharmaceutical industry customers to prepare for the implementation of a US regulation that foresees 100 percent piece level screening of ....
PPD to Evaluate US FDA Public Health Surveillance System
(Business News, 03 Dec 2009 )PPD has been awarded a contract by the US Food and Drug Administration (FDA) to evaluate the agency's Center for Drug Evaluation and Research (CDER) post-market spontaneous adverse event surveillance ....
Good Products Selected by FDAS for Regulatory Inspection
(Business News, 26 Nov 2009 )Good Products, a provider of enterprise content management solutions for the pharmaceutical and biopharmaceutical industries, has announced that its g-docs Electronic Document Management Solution has ....
Astrazeneca Withdraws Regulatory Submissions for Cancer Drug
(Business News, 12 Nov 2009 )AstraZeneca has withdrawn the regulatory submissions for the use of Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC), from the US ....
AMT Receives Orphan Drug Designation for DMD Treatment
(Business News, 22 Oct 2009 )Amsterdam Molecular Therapeutics (AMT) has announced that the European Medicines Agency (EMEA) has granted Orphan Drug Designation to the former's gene therapy product AMT-080 for the treatment of Duchenne ....
AstraZeneca: Asthma Treatment Gets Approval in Japan
(Business News, 22 Oct 2009 )AstraZeneca has announced that Symbicort Turbuhaler (budesonide/formoterol) has been approved by Japan's Ministry of Health, Labor and Welfare (MHLW). This is for the maintenance treatment of bronchial ....
