|
|
|
|
|
31 December 2014
|
USFDA
|
Guidance for Industry Bioequivalence Recommendations for Specific Products |
|
|
|
|
|
24 December 2014
|
TBT Notification
|
TBT notification issued by United States of America on Drugs |
|
|
|
|
|
20 November 2014
|
USFDA
|
FDA Requesting Comment on Proposed Criteria for “First Generic” Submissions |
|
|
|
|
|
03 November 2014
|
USFDA
|
Determination That TOPICORT (Desoximetasone) Cream and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness |
|
|
|
|
|
03 November 2014
|
USFDA
|
ANDA Submissions ― Refuse-to-Receive Standards Guidance for Industry |
|
|
|
|
|
23 October 2014
|
USFDA
|
FDA Finalizes Policy to Cut Down on Suspicious Behavior During Facility Inspections |
|
|
|
|
|
06 July 2014
|
USFDA
|
US FDA issues draft strategic priorities document |
|
|
|
|
|
03 June 2014
|
USFDA
|
Rule Change on Generic Drug Labeling Could Cost Billions |
|
|
|
|
|
26 March 2014 |
USFDA |
US FDA issues new bioavailab?ility guidelines |
|
|
|
|
|
25 March 2014
|
USFDA
|
FDA Releases New Accelerate?d Approval Labeling Guidance |
|
|
|
|
|
03 March 2014
|
USFDA
|
FDA re-evaluat?es NCE rules to incentiviz?e fixed-comb?o drugs |
|
|
|
|
|
25 October 2013
|
USFDA
|
GMP News: FDA publishes List of GMP facilities producing for the US market (generic drug products and APIs) |
|
|
|
|
|
20 October 2013
|
USFDA
|
US FDA Releases ICH Draft Guideline on Elemental Impurities |
|
|
|
|
|
27 September 2013
|
USFDA
|
Specificat?ion of the Unique Facility Identifier (UFI) System for Drug Establishm?ent Registrati?on |
|
|
|
|
|
18 September 2013
|
USFDA
|
GMP News: FDA Launches Secure Supply Chain Pilot Program |
|
|
|
|
|
13 September 2013
|
USFDA
|
FDA Guidance Establishe?s When an IND May Not be Required to Conduct Human Studies |
|
|
|
|
|
28 August 2013
|
USFDA
|
FDA has published Questions and Answers on “Guidance for Industry ANDAs: Stability Testing of Drug Substances and Products” |
|
|
|
|
|
27 August 2013
|
USFDA
|
eCTD Revisions Published by FDA, Set for June 2014 Adoption |
|
|
|
|
|
27 August 2013
|
USFDA
|
FDA Clarifies Stability Testing Requiremen?ts for Generics with New Draft Guidance |
|
|
|
|
|
19 August 2013
|
Dietry Suppliments |
With New Import Rules Set to Impact Food & Supplements, FDA to Solicit Public Feedback at Meetings |
|
|
|
|
|
19 August 2013
|
Medical Foods
|
FDA Releases Updated Draft Guidance on Medical Foods |
|
|
|
|
|
16 August 2013
|
News
|
Great Opportunity |
|
|
|
|
|
15 August 2013
|
News
|
PLAIR - new FDA Guideline regulates Import of non-approv?ed Drugs in the Run-Up to the Launch in US |
|
|
|
|
|
08 August 2013
|
News
|
US House Passes Track-and-?Trace Legislatio?n to Secure Supply Chain |
|
|
|
|
|
07 August 2013
|
USFDA
|
API, Generic Drug Facilities Hit With US FDA Fee Hikes for 2014 |
|
|
|
|
|
06 August 2013
|
USFDA/Regulatory
|
FDA Issues Guidance on Qualifying for Device User Fee Exemptions?, Reductions |
|
|
|
|
|
06 August 2013
|
USFDA / Dietary Supplemts / Regulations
|
Legislatio?n Would Create New Registrati?on, Warning Requiremen?ts for Supplement?s |
|
|
|
|
|
06 August 2013
|
USFDA
|
API, Generic Drug Facilities Hit With US FDA Fee Hikes for 2014 |
|
|
|
|
|
05 August 2013
|
News
|
Top Ten companies of USA Pharma market by Number of Prescriptions in June 2012 |
|
|
|
|
|
04 August 2013
|
USFDA
|
FDA Publishes All User Fee Rates for Fiscal Year 2014 |
|
|
|
|
|
04 August 2013
|
USFDA
|
New Requiremen?ts of the FDA on Stability Testing of Generic Drugs |
|
|
|
|
|
22 July 2013
|
USFDA
|
Circumstan?ces that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection? |
|
|
|
|
|
17 July 2013
|
USFDA/Regulatory
|
US FDA Aims to Protect Supply Chain By Detaining Adulterate?d Drugs
|
|
|
|
|
|
16 July 2013
|
USFDA
|
FDA approves Decitabine for Injection | CPhI Online |
|
|
|
|
|
15 July 2013
|
USFDA
|
Sun Pharma gets exclusivit?y for diabetes drug |
|
|
|
|
|
06 June 2013
|
News
|
US House passes pharma "track and trace" bill |
|
|
|
|
|
04 June 2013
|
News
|
USP Delays Deadline for Industry on Elemental Impurity Standards |
|
|
|
|
|
04 June 2013
|
News
|
Voluntary Drug Recalls from Fresenius, J&J and Glenmark |
|
|
|
|
|
04 June 2013
|
News
|
US House Passes Track-and-?Trace Legislatio?n to Secure Supply Chain |
|
|
|
|
|
19 May 2013
|
News
|
US House Committee Advances Track-and-?Trace Legislatio?n |
|
|
|
|
|
19 April 2013
|
News
|
US FDA: API, Generic Companies to Begin Self-ID Process for 2014 |
|
|
|
|
|
19 April 2013
|
News
|
Obama’s FY2014 Budget to Increase Foreign Manufactur?er Inspection?s |
|
|
|
|
|
17 April 2013
|
News
|
All Generic Facilities Must Re-Registe?r With FDA Starting Next Month, Agency Says |
|
|
|
|
