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FDA, Industry Agree To Set Up Enhanced Pathway For Complex Generics

FDA reached a draft user fee pact with the generic drug industry that calls for a new approval pathway for drugs with complex active ingredients and formulations, as well as for drug-device combinations.

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FDA approved Amgen’s first biosimilar product, a version of AbbVie’s Humira, Friday (Sept. 23), bringing the agency's total number of biosimilar approvals to four.

Rachel Sherman's appointment as FDA deputy commissioner for medical products and tobacco, coming nearly a year after rumors surfaced she would get the job, puts her in a formal position to shepherd high-profile agency policies.

The HHS Inspector General reports that the reimbursement scheme for home infusion inappropriately drives up the use of drugs by paying suppliers too much, but the National Home Infusion Association says the pay scheme doesn't drive overuse because physicians, not suppliers, prescribe drugs.

Utilizing big data and real-world evidence to assist in regulatory decision-making is a top priority of FDA's medical device center, according to a report published Tuesday (Sept. 20).

The House this week passed three Ways & Means bills, two of which are backed by hospitals and one of which is backed by dialysis patients and providers. 

The Senate successfully used the hotline process Thursday (Sept. 22) to advance a reauthorization of FDA's pediatric review voucher program until the end of the calendar year, leading Senate health committee Chairman Lamar Alexander (R-TN) to call for quick House passage of the short-term authorization.

FDA believes creating a new regulatory agency to oversee laboratory-developed tests would “undermine efforts to advance precision medicine” and create unnecessary bureaucracy, an agency spokesperson told Inside Health Policy after Senate health committee Chairman Lamar Alexander (R-TN) floated such a proposal at a hearing focused on LDT oversight Tuesday (Sept. 20).

Sen. Ron Johnson (R-WI) plans to ask the Senate to pass through unanimous consent next week his bill barring the federal government from interfering with states' Right To Try laws and providing liability shields to drug makers that provide patients experimental drugs.