The FDA finalized its fourth guidance dealing with biosimilars. This one focuses on formal meetings between the FDA and biosimilar sponsors or applicants. The guidance, which is slated for publication in Wednesday's Federal Register, is intended to help sponsors and applicants request a meeting with the agency to get direction on the development or review of their products. The guidance also addresses the meeting package that needs to be assembled and details best meeting management practices. "Because these meetings often will represent critical points in the regulatory process, it is important that there are efficient, consistent procedures for the timely and effective conduct of such meetings," the FDA said. When the agency released the draft guidance in April 2013, the draft raised some red flags. Concerns included inadvertent sharing of confidential information, potential use of the 351(a) path for follow-ons that rely to some extent on data from a previously approved biologic, up-front development fees, and longer proposed meeting schedules and review times for biosimilars. The FDA said it addressed the comments in the final guidance. (See BioWorld Today, June 19, 2013, and June 20, 2013.)

Although the NIH has yet to receive funding for its part of the Precision Medicine Initiative (PMI), it's forging the foundation for a national PMI cohort of at least 1 million volunteers who will provide genetic and other health data that can be used in research to better understand and improve the treatment of various diseases and conditions. The agency is offering a number of funding opportunities to develop a coordinating center, biobank, network of health care provider organizations, participant mobile technologies, a communication infrastructure to convey the importance of the research and a pilot program to inform the creation of the volunteer enrollment component. The NIH also is assembling a PMI Cohort Program Advisory Panel of outside advisers to oversee the cohort and guide the evolution of the program's vision, operations, and scientific and clinical goals. In addition, the agency has launched a nationwide search for a permanent director of the PMI Cohort Program. Pending appropriations, the agency plans to begin enrollment in the cohort next year, NIH Director Francis Collins said.

The number of inter partes review (IPR) petitions filed with the Patent Trial and Appeal Board (PTAB) that involve patents in the life sciences sector is on schedule to quadruple this year. In 2013, PTAB received 44 inter partes review petitions challenging life sciences patents. This year, the board received 165 petitions as of Sept. 30. So far, most of the life sciences patents have survived the challenges. "In general, they are faring very well. They are harder to invalidate than those in other industries during the IPR process," said Brian Nolan, a patent attorney with Mayer Brown. However, he cautioned that the IPR filings have given rise to more court proceedings that could leave drugmakers vulnerable. He advised drugmakers "to take proactive steps to insulate their patents against these vulnerabilities."

Reliance on a regulatory affairs contractor to handle its postmarketing adverse drug experience reports (PADERs) landed Heritage Pharmaceuticals Inc., of Eatontown, N.J., an FDA warning letter. Between June 2010 and June 2014, the company's annual PADERs indicated no adverse experience reports had been received for a specific drug; yet the company received about 10 individual case safety reports during that period that should have been included in the PADERs. The company didn't notice the omission until an FDA investigator pointed it out during an inspection in May, according to the letter. Heritage also was cited for having inadequate written procedures to ensure that adverse drug experiences (ADEs) are correctly assessed and reported to the FDA. For example, the agency noted the company's procedures state that ADE records are to be retained at least three years. However, FDA regulations require a 10-year retention period.

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