The latest agenda for the agency includes 59 proposed new and revised draft documents and focuses heavily on chemistry, cGMP (current good manufacturing practices), electronic drug application changes and other procedural issues. The two new documents on the list relate to pulmonary tuberculosis and the submission of study protocols for generic drugs with particular REMS (Risk Evaluation and Mitigation Strategies), though the FDA gave no indication as to why these were added for this year.
The chemistry documents expected include one on elemental impurities in drug products marketed in the US, which has been a hot topic over the past few months, especially for excipient suppliers. Many in the industry are waiting to see what will be included in the impurity tests required by the FDA as the USP (US Pharmacopeia) has pushed back its deadline for setting new specifications.
Other highly-sought-after guidance on biosimilars and the data necessary for bioequivalence studies is also expected. Australia’s TGA (Therapeutic Goods Agency) yesterday released its guidance on biosimilars and how it expects to regulate what could be a lucrative market in the coming years.
Among the manufacturing-related documents, the FDA is planning to release new guidance on “Quality Systems Approach to Pharmaceutical cGMP Regulation,” the uniformity of in-process mixtures and how to control highly potent compounds.
On the clinical trial side, the FDA plans to address pregnant women in trials and the scientific and ethical considerations, as well as new standards for clinical trial imaging endpoints.
The FDA also deleted the guidance document from an earlier list, entitled "Size and Physical Attributes of Generic Tablets," and none of the expected documents address social media, which has also been sought out by a number of pharma companies using social networks.