Issue Petitions Archives

This forum has 38 topics, and was last updated 6 years, 10 months ago by gregoryglass.

Viewing 41 topics - 1 through 41 (of 41 total)

- Topic
- Voices
- Posts
- Last Post
- Active Pharmaceutical Ingredients from Foreign Facilities
  Started by: gregoryglass
- 1
- 1
- 16 years, 5 months ago
  gregoryglass
- Alterations to Drug Labels Based on Safety Data and Considerations
  Started by: gregoryglass
- 1
- 1
- 17 years, 7 months ago
  gregoryglass
- Amend Regulations Affecting ANDA’s and ANDA Labeling
  Started by: gregoryglass
- 1
- 1
- 13 years, 2 months ago
  gregoryglass
- ANDA Eligibility for Exclusivity (Ranbaxy’s First to File Status)
  Started by: gregoryglass
- 1
- 1
- 10 years, 6 months ago
  gregoryglass
- ANDA Filings for Same Dosage Form
  Started by: gregoryglass
- 1
- 1
- 14 years, 1 month ago
  gregoryglass
- Authorized Generics
  Started by: gregoryglass
- 1
- 1
- 18 years, 4 months ago
  gregoryglass
- Authorized Generics (Concerta®(methylphenadate))
  Started by: gregoryglass
- 1
- 1
- 18 years, 4 months ago
  gregoryglass
- Biogenerics or Follow on Biologics
  Started by: gregoryglass
- 1
- 1
- 15 years, 11 months ago
  gregoryglass
- Biogenerics or Follow on Proteins or Omnitrope®(somatropin rDNA)
  Started by: gregoryglass
- 1
- 1
- 18 years, 4 months ago
  gregoryglass
- Biosimilar Application Disclosure and Patent Dispute Resolution
  Started by: gregoryglass
- 1
- 1
- 10 years, 1 month ago
  gregoryglass
- Biosimilar Interchangeability
  Started by: gregoryglass
- 1
- 1
- 8 years, 11 months ago
  gregoryglass
- Biosimilar Labeling
  Started by: gregoryglass
- 1
- 1
- 9 years, 6 months ago
  gregoryglass
- Biosimilar Naming
  Started by: gregoryglass
- 1
- 1
- 11 years, 2 months ago
  gregoryglass
- Cease Repackager Generic Pharmaceutical Services
  Started by: gregoryglass
- 1
- 1
- 13 years, 1 month ago
  gregoryglass
- Citizen Petitions — FDA Draft Guidance of January 2009
  Started by: gregoryglass
- 1
- 1
- 15 years, 10 months ago
  gregoryglass
- Country of Origin on Packaging
  Started by: gregoryglass
- 1
- 1
- 6 years, 10 months ago
  gregoryglass
- Drug Delivery Patents Listed in the Orange Book
  Started by: gregoryglass
- 1
- 1
- 13 years, 4 months ago
  gregoryglass
- Drug Dissolution Apparatuses
  Started by: gregoryglass
- 1
- 1
- 6 years, 2 months ago
  gregoryglass
- Environmental Impact of Pharmaceutical and Biologics Products
  Started by: gregoryglass
- 1
- 1
- 14 years, 4 months ago
  gregoryglass
- Expedite ANDA Review (Fosamax Plus D®(alendronate))
  Started by: gregoryglass
- 1
- 1
- 14 years, 3 months ago
  gregoryglass
- FDA Advisory Committee Meetings
  Started by: gregoryglass
- 1
- 1
- 17 years, 5 months ago
  gregoryglass
- FDA Drug Listing
  Started by: gregoryglass
- 1
- 1
- 18 years, 3 months ago
  gregoryglass
- FDA Transparency
  Started by: gregoryglass
- 1
- 1
- 14 years, 5 months ago
  gregoryglass
- Forfeiture of 180 Day Generic Exclusivity (Granisetron Injection)
  Started by: gregoryglass
- 1
- 1
- 17 years, 1 month ago
  gregoryglass
- Forfeiture of 180 days Exclusivity by delisting patent (Precose®(acarbose))
  Started by: gregoryglass
- 1
- 1
- 17 years, 1 month ago
  gregoryglass
- Good Manufacturing Practices for Highly Potent Products
  Started by: gregoryglass
- 1
- 1
- 14 years, 11 months ago
  gregoryglass
- Increase Print Size in Direct to Consumer Advertising
  Started by: gregoryglass
- 1
- 1
- 17 years, 9 months ago
  gregoryglass
- Issue Guidance Regarding Orphan Drugs
  Started by: gregoryglass
- 1
- 1
- 13 years, 2 months ago
  gregoryglass
- Issue Guidelines on Risk Based Bioequivalence Testing
  Started by: gregoryglass
- 1
- 1
- 17 years, 9 months ago
  gregoryglass
- Manufacturing Facilities
  Started by: gregoryglass
- 1
- 1
- 18 years, 4 months ago
  gregoryglass
- NDA Number Information on Product Labels
  Started by: gregoryglass
- 1
- 1
- 16 years, 7 months ago
  gregoryglass
- Off-Label Communications and Regulations
  Started by: gregoryglass
- 1
- 1
- 13 years, 5 months ago
  gregoryglass
- Orange Book Patent Listings for Pre-filled Drug Delivery Devices
  Started by: gregoryglass
- 1
- 1
- 11 years, 12 months ago
  gregoryglass
- Particulate Standards in Parenteral Drugs
  Started by: gregoryglass
- 1
- 1
- 9 years, 7 months ago
  gregoryglass
- Patent De-Listing from Orange Book (Zocor®(simvastatin))
  Started by: gregoryglass
- 1
- 1
- 18 years, 4 months ago
  gregoryglass
- Payment of Generic User Fees for Manufacturing Facilities (GDUFA)
  Started by: gregoryglass
- 1
- 1
- 11 years, 9 months ago
  gregoryglass
- PET Drugs Exemption from PDUFA User Fees
  Started by: gregoryglass
- 1
- 1
- 18 years, 4 months ago
  gregoryglass
- Pharmacies Compounding Bio-Identical Hormone Replacement Therapies
  Started by: gregoryglass
- 1
- 1
- 18 years, 4 months ago
  gregoryglass
- Phosphorus Content in Drugs
  Started by: gregoryglass
- 1
- 1
- 9 years, 8 months ago
  gregoryglass
- Prevent the Use of REMS to Block Generics
  Started by: gregoryglass
- 1
- 1
- 15 years, 5 months ago
  gregoryglass
- Waiving the 180 day Exclusivity (Neurontin®(gabapentin))
  Started by: gregoryglass
- 1
- 1
- 18 years, 3 months ago
  gregoryglass

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