The Advanced Therapy Medicinal Products Regulation has not served the EU as well as intended. Nearly a quarter of the 63 contributors to the European Commission's public consultation on the regulation have a "negative perception of the Regulation" ...

Approximately 6,000 public companies ? including medical device firms ? will be directly impacted by a US rule for companies to disclose their use of "conflict minerals" in their products, according to the Securities and Exchange Commission 1 . The ...

In 2012, 31% (34 out of 109) of the paediatric investigation plans (PIPs) that pharmaceutical companies submitted to the European Medicines Agency were sent late and missed the agency's submission deadline by six months or more 1 . Of the 34 late ...

Updated EU guidance explaining how drug companies can make changes (variations) to their marketing authorizations for human and veterinary drugs will come into force on 4 August 1 - 3 . The guidance, which the European Commission announced it had ...

The Advanced Therapy Medicinal Products Regulation has not served the EU as well as intended. Nearly a quarter of the 63 contributors to the European Commission's public consultation on the regulation have a "negative perception of the Regulation" ...

Approximately 6,000 public companies ? including medical device firms ? will be directly impacted by a US rule for companies to disclose their use of "conflict minerals" in their products, according to the Securities and Exchange Commission 1 . The ...

In 2012, 31% (34 out of 109) of the paediatric investigation plans (PIPs) that pharmaceutical companies submitted to the European Medicines Agency were sent late and missed the agency's submission deadline by six months or more 1 . Of the 34 late ...

Updated EU guidance explaining how drug companies can make changes (variations) to their marketing authorizations for human and veterinary drugs will come into force on 4 August 1 - 3 . The guidance, which the European Commission announced it had ...

The Advanced Therapy Medicinal Products Regulation has not served the EU as well as intended. Nearly a quarter of the 63 contributors to the European Commission's public consultation on the regulation have a "negative perception of the Regulation" ...

Approximately 6,000 public companies ? including medical device firms ? will be directly impacted by a US rule for companies to disclose their use of "conflict minerals" in their products, according to the Securities and Exchange Commission 1 . The ...

In 2012, 31% (34 out of 109) of the paediatric investigation plans (PIPs) that pharmaceutical companies submitted to the European Medicines Agency were sent late and missed the agency's submission deadline by six months or more 1 . Of the 34 late ...

The US Food and Drug Administration has issued final guidance explaining the various mechanisms that are available to device companies to appeal against decisions made by the agency's Center for Devices and Radiological Health 1 ,2 . The real test ...

Updated EU guidance explaining how drug companies can make changes (variations) to their marketing authorizations for human and veterinary drugs will come into force on 4 August 1 - 3 . The guidance, which the European Commission announced it had ...

Medical equipment manufacturers in China chalked up 3,828 warnings from the country's healthcare products regulator for illegal product advertising practices, in the first quarter of this year 1 . This is only a tenth of the 36,747 warnings the ...

Bayer 's oral contraceptive, Diane 35 (cyproterone acetate plus ethinylestradiol), still offers more benefits than risks, but only if actions to minimize the risk of thromboembolism are taken, says the European Medicines Agency 's Pharmacovigilance ...

Healthcare professionals in Australia currently have to trawl through more than 10 pages of pharmacology and clinical trial data in product information (PI) leaflets before they get to the usage information they are often looking for. Proposals by ...

GlaxoSmithKline , now the industry leader on the clinical trial transparency front, has given more details of its system for providing raw patient-level data to researchers for further analysis, including strict controls over who can access the data ...

The European Medicines Agency 's new policy on clinical trial data disclosure will ensure transparency in the interests of public health without impinging on a company's intellectual property rights 1 . So says the agency in publishing the final ...

The European Medicines Agency says it may appeal against interim rulings by the Court of Justice of the EU ordering it to refrain from publishing clinical trial data on AbbVie's Humira (adalimumab) and Intermune's Esbriet (pirfenidone) pending a ...