The list is long (here) and there are some interesting regulatory items found in the agenda for FDA. Take some time and peruse them all as I will just highlight a few items of interest in this post.

Here are some of the proposed rules that caught my attention:

Current Good Manufacturing Practice for Outsourcing Facilities

  • This rule would set forth the minimum current good manufacturing practice (CGMP) requirements for human drug products compounded by an outsourcing facility.

Distribution of Compounded Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act

  • If finalized, the rule will “include provisions regarding a standard memorandum of understanding (MOU) that describes the responsibilities of a State Board of Pharmacy or other appropriate State agency that chooses to sign the standard MOU in investigating complaints related to drug products compounded in such State and distributed outside such State and in addressing the interstate distribution of inordinate amounts of compounded human drug products. It will also, if finalized, include provisions regarding the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that do not sign the standard MOU.”

Pediatric Study Plan Requirements for New Drug and Biologics License Applications

  • This rule, if finalized, would implement the pediatric study plans provisions of the FD&C Act, and exercise the authority granted to the Secretary in the provisions of the FD&C Act governing exemptions from pediatric study requirements.

Transparency in Direct-to-Consumer Advertising

  • This rule will revise 21 CFR 202.1 to eliminate the option for prescription drug advertisements broadcast through media such as radio or television to fulfill the statutory brief summary requirement in section 502(n) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by disclosing risk, contraindication, and other safety information in another source beyond the advertisement itself.

Proactive Disclosure of Complete Response Letters

  • This rule will revise 21 CFR 312.130, 314.430, 601.51, and 814.9 to clarify and expand the discretion of the Commissioner of the Food and Drug Administration regarding the public release of Complete Response Letters (CRLs) and not approvable letters. This rule will eliminate the longstanding presumption that the mere existence of a marketing application constitutes confidential commercial information, thereby enabling proactive disclosure of CRLs for unapproved products while maintaining appropriate redactions for trade secrets and personal private information.

Electronic Labeling for Medical Devices

  • This rule would clarify that the adequate directions for use requirement in section 502(f) of the Federal Food, Drug, and Cosmetic Act could be satisfied when labeling is provided solely by electronic means for certain types of devices in certain circumstances. FDA anticipates that this clarification would facilitate the communication of comprehensive and up-to-date information to users to provide reasonable assurance of the safety and effectiveness of such medical devices.
  • Does this sound familiar? The Drug side of the FDA has been trying to get a similar rule for prescription drug labeling (package inserts) however at every turn the Congress has blocked funding for implementation of the rule.

These examples are just a few of the rules that are in the proposal stage and do not address any in the final stages of approval. If you have a day or two reserved for reviewing all the items in the FDA agenda, knock yourselves out! The link can be found at the top of this post.