Regulation	Description	Status
Prescription Drug Marketing	FDA is reviewing regulations promulgated under the Prescription Drug Marketing Act of 1987 and amendments of 1992 to determine if they should be amended or rescinded	Pre-rule stage; FDA was scheduled to complete the review in December 2011
Electronic Submission of Study Data	FDA is proposing to require data submitted for NDAs, BLAs and ANDAs and their supplements and amendments be provided in electronic format	Notice of Proposed Rulemaking is scheduled for March 2012 Also see "E-Submission Part Of FDA Reg Reform Plan; Alzheimer’s Data Standard About To Debut" - Pink Sheet, 29 August, 2011.
Medicare Modernization Act’s Drug Application Approval Provisions	Proposed rule would implement portions of MMA that pertain to notification of patent certifications, availability of 30-month stays of approval, submission of amendments and supplements, types of bioavailability and bioequivalence data that can be used to support applications	Notice of Proposed Rulemaking is slated for March 2012
Electronic Package Inserts (Paperless Labeling; E-labeling)	Rule would require electronic package inserts for human drug and biological prescription products in lieu of paper	Notice of Proposed Rulemaking had been scheduled for December 2011 but has not yet issued ([A#110527g1])
Revisions to cGMP Requirements for Finished Pharmaceuticals (2^ndPhase)	Rule is the second increment of modifications to cGMP regulations; a final rule on the first increment was published in 2008	Notice of Proposed Rulemaking is slated for March 2012
Citizen Petitions and Petitions For Stay of Action	Rule will implement provisions of the Food and Drug Administration Amendments Act	Proposed rule was published in the Federal Register on Jan. 3
Additions To List of Tropical Diseases Eligible For Priority Review Voucher	Rule will designate tropical diseases to be added to the list in the Food, Drug and Cosmetic Act; sponsors of products to treat these diseases may qualify for a priority review voucher	Notice of Proposed Rulemaking is scheduled for March 2012
cGMP For Components of Finished Pharmaceuticals	Rule amends cGMP regulations regarding control over components used in manufacturing finished pharmaceuticals	Notice of Proposed Rulemaking scheduled for March 2012
Orphan Drug Amendments	Rule will clarify issues, such as eligibility for orphan drug designation, eligibility for multiple orphan drug exclusive approvals and the requirement for demonstrating clinical superiority	NPRM comment period ended Jan. 17, 2012 Also see "Orphan Disclosures Could Increase Under Tweaks Proposed By FDA" - Pink Sheet, 18 October, 2011..
Registration and Listing Of Drugs	Rule clarifies when, where and how to register drug establishments and list drugs	Final rule is expected in October 2012
cGMP for Combination Products	Rule clarifies and codifies cGMP requirements for combinations of a drug, device and/or biological product	Final rule is slated for May 2012 Also see "FDA Combination Products Office Finalizing Manufacturing, Adverse Event Rules" - Pink Sheet, 25 April, 2011.
Post-market Safety Reporting for Combination Products	Rule describes post-market safety reporting requirements for combination products	Final rule is scheduled for June 2012
Electronic Submission of Post-marketing Safety Reports	Rule will require safety reports to be transmitted in an electronic format	Final rule is expected in March 2012
Sterility Testing for Biological Products	Rule will amend sterility testing requirements for biological products	Final rule is scheduled for March 2012
Clinical Investigator Disqualification	FDA is proposing to amend regulations to expand the scope of clinical investigator disqualification	Final rule is slated for April 2012 Also see "Clinical Researcher Debarments Proceeding Slowly, Despite FDA Promises Of Reform" - Pink Sheet, 8 August, 2011.
Safeguards for Children in Clinical Investigation	Rule provides additional safeguards for children enrolled in clinical investigations of FDA regulated trials	Final rule is slated for April 2012

FDA’s Rulemaking To-Do List Includes Clarifying Citizen Petitions And Orphan Drug Designations

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