• Regulatory NewsRegulatory News

    Health policy experts call for stronger accelerated approval reforms

    The US Congress should take concerns raised by the Food and Drug Administration (FDA) seriously and give the agency more authority around accelerated approvals, including the power to expedite the withdrawal of drugs from the market, according to a perspective article from three experts on drug regulation and health policy.   The perspective, written by Rachel E. Sachs, JD, MPH, of Washington University in St. Louis, Julie M. Donohue, PhD, of the University of Pittsbur...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Spring regulatory agenda, upcoming guidances, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we get a glimpse at FDA’s Spring regulatory agenda and get tips on several upcoming guidances. Plus, we learn about a new 510(k) pilot program for CBER-regulated medical devices.   Next week, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will ...
  • Regulatory NewsRegulatory News

    Burr chastises FDA at second Senate user fee hearing

    Sen. Richard Burr (R-NC) continued to criticize the US Food and Drug Administration (FDA) for failing to provide lawmakers a Medical Device User Fee Amendments (MDUFA V) deal and for not publishing meeting minutes with industry on time. His comments came during the second user fee reauthorization hearing in the Senate Health, Education, Labor and Pensions (HELP) committee.   On 26 April, the directors of FDA’s medical product centers sat before the HELP committee to ...
  • Regulatory NewsRegulatory News

    Shuren apologizes for MDUFA delay, says FDA will start closing the spigot on new EUAs

    The head of the US Food and Drug Administration’s (FDA) device center was criticized by top House lawmakers for not getting a Medical Device User Fee Amendments (MDUFA V) deal to them for review on time. He apologized for missing the statutory deadline and noted his staff have been slammed due to the COVID-19 pandemic.   On 30 March, the House Energy and Commerce (E&C) subcommittee on health met to discuss renewing FDA’s MDUFA program . At the start of the meeting c...
  • Regulatory NewsRegulatory News

    MDUFA V: Commitment letter includes TPLC pilot, claw back provisions and more

    The new medical device user fee deal includes the US Food and Drug Administration’s (FDA) total product lifecycle (TPLC) advisory program, or TAP, as well as new guidance development requirements and claw back provisions that let industry renegotiate fees. If signed into law as is, it would bring in $1.78-$1.9 billion over the next five years.   FDA finally published a commitment letter on 22 March summarizing the Medical Device User Fee Amendments (MDUFA V) deal i...
  • Regulatory NewsRegulatory News

    FDA issues proposed OTC hearing aid rule

    The US Food and Drug Administration (FDA) has issued a long-awaited proposed rule to create a new regulatory category that would allow the sale of over-the-counter (OTC) hearing aids for adults with mild and moderate hearing loss.   Implementing the proposed rule would make good on requirements established by the Over-the-Counter Hearing Aid Act of 2017 passed as a provision of the FDA Reauthorization Act of 2017 . The act directed FDA to create a report available f...
  • RAPS' LatestRAPS' Latest

    New book covers essential lessons of Rx-to-OTC switch

    More than ever, consumers are looking to over-the-counter (OTC) medicines for treatment options that are easily accessible and often less costly than prescription alternatives. The OTC market in the US is growing. Sales are expected to grow from the $25 billion spent in 2013 to an estimated $42 billion in 2024, a 68% increase. When a prescription medicine is reclassified to be made available without a prescription, it is known as an Rx-to-OTC switch. In such cases, the ...
  • Regulatory NewsRegulatory News

    Three foreign OTC firms slapped with warning letters for GMP testing violations

    Slipshod testing of two over-the-counter (OTC) analgesics along with improper marketing of one led the US Food and Drug Administration (FDA) to issue three warning letters to manufacturers located outside the US. Additionally, the agency continued its crackdown on imported hand sanitizers.   The recipients of the warning letters, which were all issued in mid-September, include Laboratorio Pharma International in Tegucigalpa, Honduras, a manufacturer of antibiotics and ...
  • Regulatory NewsRegulatory News

    FDA’s novel excipient pilot program opens for candidates

    The US Food and Drug Administration (FDA) has launched a new pilot program to review novel excipients for use in meeting unmet needs in formulating new drug products. The pilot has the full support of the pharmaceutical industry.   FDA called the program “a new pathway for manufacturers to obtain FDA review of certain novel excipients (inactive ingredients) prior to their use in drug formulations,” according to a 7 September announcement.   Excipients are inactiv...
  • Regulatory NewsRegulatory News

    FDA says Turkish OTC maker’s testing program earns failing grades

    The US Food and Drug Administration (FDA) criticized a Turkish manufacturer of over-the-counter drugs for failing to test incoming ingredients and to test products before releasing them to the market in a recent warning letter . The company was also warned for its lax approach to stability testing.   The 13 May letter to Istanbul-based Gulsah Uretim Kozmetik Sanayi Anonim Sirketi follows up on FDA’s review of a 23 April response to request for records. The firm is the...
  • ReconRecon

    Recon: Novartis' Leqvio nabs NICE nod; HebeCell makes a foray into CAR-NK space

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US When Will the Delta Surge End? ( NYT ) Why can’t America fix its Covid-19 testing problems? ( VOX ) Vaccination Rates Rose In August As COVID Cases Surged Due To The Delta Variant ( NPR ) First vaccination doses up 17 percent since Pfizer approval: analysis ( The Hill ) Companies eye financial penalties for unvaccinated workers ( The Hill ) America has waste...
  • Regulatory NewsRegulatory News

    FDA's FY2022 Senate funding bill clears Appropriations committee

    The Senate Appropriations committee has completed its markup of the FY2022 budget for the US Food and Drug Administration (FDA), advancing by a 25-5 vote a bill that would hold the agency to a $200 million increase in its budget authority.   The bill exited the Appropriations subcommittee responsible for FDA funding on Monday with no objections to the Senate’s proposed 6% increase for the agency over FY2021 figures. (RELATED: Senate subcommittee advances FY2022 FDA f...