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Regulatory and Legal

Search Results 1 - 10 of 152 records

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AstraZeneca has withdrawn the regulatory submissions for the use of Zactima (vandetanib) 100mg in combination with chemotherapy in patients with advanced non-small cell lung cancer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 ....

API: The Right Choice

(Cover Story, Oct 2009 )

The US Food and Drug Administration (FDA) is ramping up regulatory efforts with funding and reform. Generic drugs are becoming increasingly visible because of their importance in healthcare. How do companies ....

Sinovac Obtains Production License for H1N1 Vaccine

(Top News, 09 Sep 2009 )

Sinovac Biotech has announced that the State Food and Drug Administration (SFDA) has approved the registration application for Panflu.1, a H1N1 vaccine, and has issued a production license for this vaccine. ....

ViroMed Receives Approval of Phase II Trial for Peripheral Artery Disease Drug

(Business News, 24 Jul 2009 )

ViroMed has announced that VM202-PAD, a Deoxyribonucleic Acid (DNA) medicine for the treatment of Peripheral Artery Disease (PAD), has received approval from the US Food and Drug Administration (FDA) ....

Wyeth Receives Approval for Arthritis Drug

(Business News, 23 Jul 2009 )

Wyeth has received approval from the Japanese Ministry of Health, Labor and Welfare to add the indication of treating polyarticular Juvenile Idiopathic Arthritis (JIA) to "Enbrel 25mg for SC Injection," ....

Watson Receives FDA Response on Cancer Drug

(Business News, 16 Jul 2009 )

Watson Pharmaceuticals has received a Complete Response Letter from the US Food and Drug Administration (FDA) on its New Drug Application (NDA) for Trelstar 22.5 mg (triptorelin pamoate for injectable ....

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Drug Discovery

Drug Development

Drug Manufacturing

Drug Delivery

Clinical Trials

Regulatory and Legal

Alliances and Mergers

QA/QC and Compliance

Pharmaceutical Processing and Packaging

Regulatory and Legal

PPD to Evaluate US FDA Public Health Surveillance System

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

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

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

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

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 ....

API: The Right Choice

The US Food and Drug Administration (FDA) is ramping up regulatory efforts with funding and reform. Generic drugs are becoming increasingly visible because of their importance in healthcare. How do companies ....

Sinovac Obtains Production License for H1N1 Vaccine

Sinovac Biotech has announced that the State Food and Drug Administration (SFDA) has approved the registration application for Panflu.1, a H1N1 vaccine, and has issued a production license for this vaccine. ....

ViroMed Receives Approval of Phase II Trial for Peripheral Artery Disease Drug

ViroMed has announced that VM202-PAD, a Deoxyribonucleic Acid (DNA) medicine for the treatment of Peripheral Artery Disease (PAD), has received approval from the US Food and Drug Administration (FDA) ....

Wyeth Receives Approval for Arthritis Drug

Wyeth has received approval from the Japanese Ministry of Health, Labor and Welfare to add the indication of treating polyarticular Juvenile Idiopathic Arthritis (JIA) to "Enbrel 25mg for SC Injection," ....

Watson Receives FDA Response on Cancer Drug

Watson Pharmaceuticals has received a Complete Response Letter from the US Food and Drug Administration (FDA) on its New Drug Application (NDA) for Trelstar 22.5 mg (triptorelin pamoate for injectable ....

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