Capture.JPG

Importance of conducting proper research to prove safe and effective medical uses for the active chemicals in marijuana and its components

Marijuana is a Schedule I compound with known risks

  • Safety and effectiveness in treatment of medical disorders held to the same standard as other drug compounds
  • FDA approved purified form of drug cannabidiol (CBD) to treat seizures with rare, severe forms of epilepsy
  • Approval based on well-controlled clinical trials, reliable  dosage form, through  reproducible route of delivery to ensure anticipated benefits

Path for other marijuana-derived products 

  • Robust clinical development program, purity and  manufacturing controls
  • FDA Botanicals Team with expertise on botanical issues
  • Involvement of other federal agencies- National Institute on Drug Abuse, Drug Enforcement Administration
  • Continued vigilance of illegal marketing of unapproved CBD-containing products with unproven medical claims

READ


Capture

Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis

Summary:

Public workshop held on “Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis.”

Purpose:

Discuss the clinical trial design challenges and future considerations for inhaled antibacterial products to treat cystic fibrosis (CF) and non-CF bronchiectasis.

READ


Capture.JPG

Quality Metrics for Drug Manufacturing

Quality metrics

  • Used throughout drugs and biologics industry to monitor quality control
  • Foundation for continual improvement of product and process quality
  • Element of companies’ commitment to quality culture

Two new programs on use of quality metrics to modernize pharmaceutical quality systems and advance innovation

  1. Quality Metrics Feedback Program: New drugs, generics, pharmaceutical ingredients (API) establishments, contract manufacturing organizations (CMOs), OTC products
  2. Quality Metrics Site Visit Program:  Experiential and firsthand learning opportunities to FDA staff i

Provide an opportunity for FDA to continue learning about the advantages and challenges companies have experienced in implementing Quality Systems

READ


Capture.JPG

Continued efforts relating to compounded drugs for patients who cannot use an FDA-approved drug

Compounded drugs are not FDA-approved

  • Quality of products important
  • Developing policies and conducting oversight to minimize risks to patients
  • Taking actions to protect patients and enforce existing laws

Fraud enforcement actions 

  • Billing reimbursors for medically unnecessary compounded drugs
  • Examples: topical pain creams comprised of multiple ingredients to increase billing amount, include non-topical products such as antidepressants, anticonvulsants, antivirals, narcotics
  • Clinicians and patients not aware of potential safety risks, lack of effectiveness

FDA Actions:

  • Draft guidance on evaluation of  clinical need
  • Inspection of compounding facilities
  • Prescription requirement

READ


Image credit: FDA

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google+ photo

You are commenting using your Google+ account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

w

Connecting to %s