Whenever a new drug is disapproved, FDA issues a complete response letter (CRL) to the manufacturers citing all the reasons why it was rejected. These letters contain details of the applicant’s development program with specific deficiencies identified and potential solutions offered. The CRL becomes the roadmap for the applicant to satisfy FDA’s concerns and eventual … Read more
In its efforts to rein in drug advertisement in the digital age, FDA has published several guidance documents and rules to clarify and advise about acceptable marketing practices. There is a guidance on use of website content and twitter among others that advise about FDA’s expectations. However, there is little advice from FDA about adequate digital ads such as … Read more
When FDA audits a company and find smajor deficiencies followed by publicly disclosing its findings, other regulatory agencies in the rest of the world also take notice. Hospira learnt it the hard way recently when Health Canada banned products manufactured at Hospira’s facility in Italy specifically citing the “reliability of the laboratory data” and FDA’s … Read more
