FDA, Pharmacy and regulatory writing...........

I got interested for a career in medical writing......

(https://www.kent.ac.uk/careers/workin/sciencewriting.htm)

Though I have a immense number of medical publications, I had not much knowledge of regulatory writing. So, I had to learn from scratch.  It had  a steep learning curve, but the journey was exciting.
Had to be familiarized with  a number of acronyms......
AE = Adverse Event
BIMO = Bioresearch Monitoring program
CER=Clinical Evaluation Reports
CPM = Clinical Project Manager
CRC = Clinical Research Coordinator
CRF = Case Report Form
CFR = Code of Federal Regulations
CRA = Clinical Research Associate
CRO = Contract Research Organization
EDC = Electronic Data Capture
FCE = Field Clinical Engineer
FDA = Food and Drug Administration
FDF = Financial Disclosure Form
ICF = Informed Consent Form
IDE = Investigational Device Exemption
IMV = Interim Monitoring Visits
IND = Investigational New Drug
IRB = Institutional Review Board
MP = Monitoring Plan
NDA = New Drug Application
PI = Principal Investigator
PMA = Pre Market Approval
QC = Quality Check
RBM = Risk Based Monitoring
RMP = Risk Management Plan
TMF = Trial Master File
SAE = Serious Adverse Event
SSR=Safety Surveillance Reports
WL = Warning Letter
483 = Inspectional Findings


FDA categorizes medical devices into three classes
Class I : low risk and subject to the least regulatory controls
Class III : highest risk devices and subject to the highest level of regulatory control, often requiring agency approval before they can be marketed.