Principles and Practice of Pharmaceutical Medicine

emergent safety issue, or ‘routine’. Pivotal clinical trials in a submitted NDA or BLA will usually garner an inspection of the ...

applicant. These meetings can also be held by telephone conference, and FDA is getting quite good at accepting electronic files ...

that has been gathered subsequent to the filing of the NDA. Federal law requires that FDA issue a notice of action within 180 da ...

CBER has innovated further with documents entitled ‘Points to Consider’. These rank below guidances in terms of their gravity. T ...

31.9 Developments during 2005 The year 2005 was tumultuous at the FDA for numerous reasons. However, there was one event that is ...

32 Special US Regulatory Procedures: Emergency and Compassionate INDs and Accelerated Product Approvals Anthony W. Fox 32.1 Intr ...

Unapproved drugs in clinical research are termed investigational drugsorbiologics. Normally, a 30-day waiting period applies whe ...

even aware of these nuances in the IND regula- tions. Reimbursement systems in the United States will, however, often refuse to ...

minimum needed to assure patient safety. These abbreviated INDs are otherwise of orthodox composition (21CFR para 312.23), and h ...

It is also specified how FDA may withdraw approval, which is usually threatened when the sponsor fails to conduct post-marketing ...

and with all due diligence. Regulators often have no experience of clinical study management, and the difficulties of studying t ...

Information Act, which provides free access to the Summary Basis of Approval document for all approved drugs in the United State ...

by pharmaceutical companies, and they have all been developed with a lot of industry input. By these measures, they can be judge ...

33 The Development of Human Medicines Control in Europe from Classical Times to the Year 2000 1 John P. Griffin 33.1 The evoluti ...

individually, he evaluated them experimentally on condemned criminals. He then compounded all the effective substances into one ...

Paul of Aegina was the last of the physicians of the Byzantine culture to practice in Alexandria, which fell to the Arabs in his ...

and druggists, founded the pharmaceutical society and became the pharmacists as we know them today. The Apothecaries were origin ...

obligatory formularies: Barcelona in 1535 (Con- cordia Pharmacolorum Barcinonesium); Nurem- berg in 1546 (Dispensatorium Valerii ...

wasted no time in enforcing their new powers out- side the City of London [24]. The following is a synopsis of their visitations ...

After their round of inspections the group retired to a hostelry where at 16.00 h they sat down to dinner, at the College’s expe ...